Small Cell Lung Carcinoma Extensive DiseasePhase 3CANTABRICONCT04712903
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 3 study testing Durvalumab, Cisplatin and Etoposide in people with Small Cell Lung Carcinoma Extensive Disease, run by AstraZeneca at 34 sites in Spain.
Trial summary
This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Small Cell Lung Carcinoma Extensive Disease
- What is being tested?
- Durvalumab, Cisplatin and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 34 sitesSpain
- Study dates
- 16 Dec 2020to 21 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented Small cell Lung Cancer with extensive disease.
- Patients who had received chemoradiotherapy for LS-SCLC and have experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle, can be included under investigator criteria.
- Brain metastases; must be asymptomatic or have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent.
- Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for ES-SCLC.
- ECOG Performance Status of 0-2 at enrolment.
- No prior exposure to immune-mediated therapy for cancer.
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- Adequate hematologic and organ function.
- Life expectancy of at least 12 weeks.
- Body weight >30 kg.
Who cannot join
- Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
- Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
- Active infection including tuberculosis, HIV, hepatitis B anc C
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Spain34 sites
Research Site
A Coruña, 15006
Research Site
Alicante, 03010
Research Site
Badajoz, 6006
Research Site
Badalona, 08916
Research Site
Barcelona, 08036
Research Site
Barcelona, 08908
Research Site
Barcelona, 8003
Research Site
Barcelona, ?08041
Research Site
Castellon, 12004
Research Site
Córdoba, 14004
Research Site
Galdakao, 48960
Research Site
Granada, 18014
Research Site
Jaén, 23007
Research Site
León, 24071
Research Site
Madrid, 28027
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Majadahonda, 28222
Research Site
Málaga, 29011
Research Site
Mataró, 08304
Research Site
Murcia, 30008
Research Site
Ourense, 32005
Research Site
Oviedo, 33011
Research Site
Palma, 07198
Research Site
Reus,Tarragona, 43204
Research Site
San Cristóbal de La Laguna, 38320
Research Site
San Sebastián, 20014
Research Site
Santander, 39008
Research Site
Santiago de Compostela, 15706
Research Site
Toledo, 45004
Research Site
Valencia, 46026
Research Site
Valladolid, 47003
Research Site
Zaragoza, 50009
About this study
Official title: A Phase IIIB, Single Arm Study, of Durvalumab in Combination With Platinum-Etoposide for Untreated Patients With Extensive-Stage Small Cell Lung Cancer Reflecting Real World Clinical Practice in Spain (CANTABRICO).
This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.
Read the detailed description
This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.
- Being tested
- Durvalumab, Cisplatin, Etoposide, Carboplatin
- Keywords
- Extensive-Stage, ICI, SCLC, Durvalumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.
CisplatinDrug
Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.
EtoposideDrug
Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.
CarboplatinDrug
Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab in Combination with Platinum-Etoposide | Experimental | Durvalumab 1500 mg via IV infusion will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity. Receives: Drug: Durvalumab; Drug: Cisplatin; Drug: Etoposide; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events (AEs) Grade ≥ 3
Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
Measured: During study treatment, until disease progression (median 6 months)
Number of Patients With Immune-mediated Adverse Events (imAE)
Patients with immune-mediated adverse events (imAE) per patient
Measured: During study treatment, until disease progression (median 6 months)
Secondary outcomes (36)
Progression Free Survival (PFS).
PFS: Defined as the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from investigational product or receives another anticancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable assessment.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Objetive Response Rate (ORR)
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) Criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: At least every 12 weeks, up to 18 monts
Duration of Response (DoR)
DoR: Defined as the time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.
Measured: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.
Time to Treatment Discontinuation (TTD)
TTD: Defined as the time from the first date of treatment until the end of treatment date.
Measured: From the first date of treatment until the end of treatment date, assessed up to 2 years.
Overal Survival (OS)
OS: Defined as the time from the first date of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Measured: From date of inclusion until the date of death, assessed up to 30 months
PFS Rate at 6 Months
Percentage of participants remaining alive without disease progression at 6 months after initiation of study treatment.
Measured: Every 12 weeks
PFS Rate at 12 Months
Percentage of participants remaining alive without disease progression at 12 months after initiation of study treatment.
Measured: Every 12 weeks
DoR Rate at 12 Months
Percentage of responders remaining alive without disease progression at 12 months after first response.
Measured: Every 12 weeks
OS Rate at 6 Months
Percentage of participants remaining alive at 6 months after initiation of study treatment.
Measured: Every 12 weeks
OS Rate at 12 Months
Percentage of participants remaining alive at 12 months after initiation of study treatment.
Measured: Every 12 weeks
OS Rate at 18 Months
Percentage of participants remaining alive at 18 months after initiation of study treatment.
Measured: Every 12 weeks
EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
. EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit
EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).
For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit
EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.
Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.
Change from baseline is the difference in the score between the end of treatment visit and the first visit.
Measured: Baseline (cycle 1 day 1) and end of treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start16 Dec 2020
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung Carcinoma Extensive DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dolores Isla, M.D., Principal investigator, Hospital Clínico Lozano Blesa, Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712903
- Sponsor's protocol ID
- D419QC00005
- Other IDs
- 2020-002328-35
- Acronym
- CANTABRICO
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2020
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Publications
Piedra A, Guinart-Cuadra A, Martinez-Recio S, Mulet M, Zamora C, Osuna-Gomez R, Canto E, Ortiz MA, Alejandre J, Barba A, Sanz-Beltran J, Serra-Lopez J, Isla D, Arriola E, Paz-Ares L, Diz-Tain MP, Moreno AL, Callejo A, Vidal S, Majem M. Baseline PD-L1 expression on circulating immune cells as a predictor of survival and immune-related adverse events in extensive-stage small-cell lung cancer patients treated with durvalumab and carboplatin-etoposide (NCT04712903 Trial). J Transl Med. 2026 Feb 28;24(1):471. doi: 10.1186/s12967-026-07896-7.
PubMed 41764558Isla D, Zugazagoitia J, Arriola E, Garcia-Campelo R, Marti Blanco C, Diz-Tain MP, Lopez-Brea M, Moreno-Vega AL, Leon-Mateos L, Oramas J, Gutierrez-Calderon V, Majem M, Sanchez-Hernandez A, Aguado C, Alvarez-Cabellos R, Massuti B, Moreno A, Firvida-Perez JL, Valdivia J, Gonzalez-Cordero M, Zafra-Poves M, Domine M, Garcia-Navalon FJ, Villanueva N, Provencio M, Juan-Vidal O, Rivas-Corredor C, Olmedo Garcia ME, Palmero R, Lopez-Castro R, Carcereny E, Lechuga JL, Dominguez M, Callejo A, Paz-Ares L. Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial. Lung Cancer. 2025 Nov;209:108763. doi: 10.1016/j.lungcan.2025.108763. Epub 2025 Sep 24.
PubMed 41033130
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB, Single Arm Study, of Durvalumab in Combination With Platinum-Etoposide for Untreated Patients With Extensive-Stage Small Cell Lung Cancer Reflecting Real World Clinical Practice in Spain (CANTABRICO).
- ClinicalTrials.gov ID
- NCT04712903
- Acronym / sponsor ID
- CANTABRICO / D419QC00005
- Keywords
- Extensive-Stage, ICI, SCLC, Durvalumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Posted 7 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.
Detailed description
This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab in Combination with Platinum-Etoposide | Experimental | Drug: Durvalumab, Drug: Cisplatin, Drug: Etoposide, Drug: CarboplatinDurvalumab 1500 mg via IV infusion will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically documented Small cell Lung Cancer with extensive disease.
- Patients who had received chemoradiotherapy for LS-SCLC and have experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle, can be included under investigator criteria.
- Brain metastases; must be asymptomatic or have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent.
- Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for ES-SCLC.
- ECOG Performance Status of 0-2 at enrolment.
Key exclusion criteria (5 listed)
- Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
- Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
- Active infection including tuberculosis, HIV, hepatitis B anc C
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabDurvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle. | Drug | Durvalumab in Combination with Platinum-Etoposide |
| CisplatinCisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle. | Drug | Durvalumab in Combination with Platinum-Etoposide |
| EtoposideEtoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle. | Drug | Durvalumab in Combination with Platinum-Etoposide |
| CarboplatinCarboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle. | Drug | Durvalumab in Combination with Platinum-Etoposide |
Primary outcome
Number of Patients With Adverse Events (AEs) Grade ≥ 3
Time frame: During study treatment, until disease progression (median 6 months)
Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
Number of Patients With Immune-mediated Adverse Events (imAE)
Time frame: During study treatment, until disease progression (median 6 months)
Patients with immune-mediated adverse events (imAE) per patient
36 secondary outcomes
Progression Free Survival (PFS).
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Objetive Response Rate (ORR)
Time frame: At least every 12 weeks, up to 18 monts
Duration of Response (DoR)
Time frame: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.
Time to Treatment Discontinuation (TTD)
Time frame: From the first date of treatment until the end of treatment date, assessed up to 2 years.
Overal Survival (OS)
Time frame: From date of inclusion until the date of death, assessed up to 30 months
PFS Rate at 6 Months
Time frame: Every 12 weeks
PFS Rate at 12 Months
Time frame: Every 12 weeks
DoR Rate at 12 Months
Time frame: Every 12 weeks
OS Rate at 6 Months
Time frame: Every 12 weeks
OS Rate at 12 Months
Time frame: Every 12 weeks
OS Rate at 18 Months
Time frame: Every 12 weeks
EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
. EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit
Time frame: Baseline (cycle 1 day 1) and end of treatment visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41764558Piedra A, Guinart-Cuadra A, Martinez-Recio S, Mulet M, Zamora C, Osuna-Gomez R, Canto E, Ortiz MA, Alejandre J, Barba A, Sanz-Beltran J, Serra-Lopez J, Isla D, Arriola E, Paz-Ares L, Diz-Tain MP, Moreno AL, Callejo A, Vidal S, Majem M. Baseline PD-L1 expression on circulating immune cells as a predictor of survival and immune-related adverse events in extensive-stage small-cell lung cancer patients treated with durvalumab and carboplatin-etoposide (NCT04712903 Trial). J Transl Med. 2026 Feb 28;24(1):471. doi: 10.1186/s12967-026-07896-7.
- Derived from this study: PubMed 41033130Isla D, Zugazagoitia J, Arriola E, Garcia-Campelo R, Marti Blanco C, Diz-Tain MP, Lopez-Brea M, Moreno-Vega AL, Leon-Mateos L, Oramas J, Gutierrez-Calderon V, Majem M, Sanchez-Hernandez A, Aguado C, Alvarez-Cabellos R, Massuti B, Moreno A, Firvida-Perez JL, Valdivia J, Gonzalez-Cordero M, Zafra-Poves M, Domine M, Garcia-Navalon FJ, Villanueva N, Provencio M, Juan-Vidal O, Rivas-Corredor C, Olmedo Garcia ME, Palmero R, Lopez-Castro R, Carcereny E, Lechuga JL, Dominguez M, Callejo A, Paz-Ares L. Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial. Lung Cancer. 2025 Nov;209:108763. doi: 10.1016/j.lungcan.2025.108763. Epub 2025 Sep 24.
- CSR SynopsisLink provided by the sponsor.
- SAPLink provided by the sponsor.
- ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dolores Isla, M.D. principal investigator
Hospital Clínico Lozano Blesa, Zaragoza
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Durvalumab, Cisplatin and Etoposide in people with Small Cell Lung Carcinoma Extensive Disease, run by AstraZeneca at 34 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Events (AEs) Grade ≥ 3 (time frame: During study treatment, until disease progression (median 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04712903, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.