Non-Small Cell Lung CancerPhase 2AZENTNCT02841579
Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M
A Phase 2 study testing Osimertinib in people with Non-Small Cell Lung Cancer, run by MedSIR at 7 sites in Spain.
Trial summary
The primary goal is to evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria. Safety and efficacy will also be measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesSpain
- Study dates
- 2 Sep 2016to 14 Feb 2020
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or older
- Patients with histological confirmation of locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with an activating EGFR mutation and concomitant T790M mutation who are not candidates for local curative treatment.
- Patients with a M1a stage according to the TNM version 7 including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease that is not a candidate for curative treatment (including patients who progress after chemoradiotherapy in stage III disease).
- Patients with a EGFR deletion or mutation in exon 19, exon 21 (L858R, L861Q) or exon 18 (G719X) and concomitant T790M mutation before treatment confirmed centrally.
- ECOG (Eastern Cooperative Oncology Group) performance status less than or equal to 2.
- Existence of measurable or evaluable disease (as per RECIST 1.1 criteria). Patients with asymptomatic and stable brain metastases are eligible for the study.
Show all 20Show fewer
- Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumor or metastatic tumor tissue, within the 60 days prior to study entry.
- Life expectancy ≥12 weeks.
- Adequate hematologic function:
- Absolute neutrophil count (ANC) > 1.5 x 109/L
- platelet count > 100.0 x109/L
- hemoglobin > 9.0 g/dL (> 6.2 mmol/L).
- Adequate coagulation: INR ≤ 1.5.
- Adequate liver function
- Adequate renal function.
- Capacity to swallow, patient capable of completing treatment and accessible, ensuring proper follow-up.
- Patients able to complete study and within geographical proximity allowing for adequate follow-up.
- Resolution of all acute toxic effects of previous anti-cancer therapy (which can only be adjuvant or neoadjuvant) or surgical interventions not exceeding grade ≤ 1 according to the NCI CTCAE version 4.0 (except for alopecia or other side effects that the investigator does not consider to be a risk to patient safety).
- All men or women of childbearing potential must use a contraception method during the study treatment and for at least 12 months after the last dose of the study drug.
- Signed and dated informed consent form
Who cannot join
- Locally advanced lung cancer candidate for curative treatment through radical surgery and/or radio(chemo)therapy.
- Patients diagnosed with another lung cancer subtype, patients with mixed NSCLC with predominantly squamous cell cancer, or with any small-cell lung cancer component.
- Patients with a EGFR deletion or mutation in exon 19, exon 21 (L858R, L861Q) or exon 18 (G719X) and concomitant T790M mutation before treatment that have not been confirmed centrally.
- Patients who have received prior antineoplastic treatment for advanced disease.
- Second active neoplasia
- Patients with just one measurable or evaluable tumor lesion that has been resected or irradiated prior to their enrollment in the study.
Show all 21Show fewer
- Medical history of Interstitial Lung Disease (ILD) induced by drugs, radiation pneumonitis requiring steroid treatment or any evidence of clinically active ILD.
- Corrected QT Interval (QTc) >470 msec, obtained from 3 ECGs at rest, using the QTc value determined according to the clinical screening ECG machine.
- Any clinically significant abnormality in ECG rhythm, conduction or morphology at rest.
- Any factor that increases the risk of QTc prolongation or risk of irregular heartbeat or sudden inexplicable death under the age of 40 in first-degree relatives or any concomitant medications that prolong the QT interval.
- Uncontrolled, active or symptomatic metastases of CNS, carcinomatous meningitis or leptomeningeal disease indicated by known clinical symptoms, cerebral edema and/or progressive neoplasia. Patients with history of CNS metastasis or compression of the spinal cord are eligible if they have received local final treatment (e.g., radiotherapy, stereotactic surgery) and if they have remained clinically stable without using anticonvulsants and corticosteroids for a minimum of 4 weeks prior to the first day of study treatment.
- Refractory nauseas and vomiting, chronic gastrointestinal disease, inability to swallow study drug or significant intestinal resection that restricts the adequate absorption of osimertinib (AZD9291).
- Patients who have had a surgical procedure unrelated to the study within 7 days prior to the administration of the drug or a significant traumatic lesion during the 4 weeks prior to starting the administration of the study drug, patients who have not recovered from the side effects of any major surgery or patients who might need major surgery during the course of the study.
- Pregnant or breastfeeding women. Women of childbearing potential, including women who had their last menstrual period within the last two years, must have a negative serum or urine pregnancy test in the 7 days prior to the start of the treatment.
- Patients who are not willing to use an adequate contraception method until 12 months after the last dose of study treatment.
- Patients with a serious concomitant systemic disorder (e.g., active infection, including HIV or heart disease) that is incompatible with the study (in the opinion of the investigator), history of bleeding diathesis or anticoagulant therapy (the use of low molecular weight heparin is permitted provided that it is used for prophylaxis).
- Patients with a history of cancer that has been completely treated, with no evidence of malignant disease currently cannot be enrolled in the study if their chemotherapy was completed less than 6 months prior and/or have received a bone marrow transplant less than 2 years before the first day of study treatment.
- Prior treatment with cytotoxic chemotherapy for advanced NSCLC; neoadjuvant/adjuvant chemotherapy is permitted if at least 6 months have elapsed between the end of chemotherapy and the first day of study treatment.
- Patients who have received prior EGFR treatments for lung cancer.
- Patients who have received treatment with an investigational drug within 3 weeks before the first day of study treatment.
- Treatment with prohibited drugs within 14 days before the first day of study treatment.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
MedSIR Investigative Site
A Coruña, 15706
MedSIR Investigative Site
Barcelona, 08026
MedSIR Investigative Site
Barcelona, 08028
MedSIR Investigative Site
Bilbao, 48903
MedSIR Investigative Site
Madrid, 28006
MedSIR Investigative Site
Málaga, 29010
MedSIR Investigative Site
Valencia, 46015
About this study
Official title: A Phase IIa Clinical Trial to Evaluate the Safety and Efficacy of Osimertinib (AZD9291) in First-line Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC and Concomitant EGFR T790M Mutation at Time of Diagnosis
The primary goal is to evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria.
Safety and efficacy will also be measured.
Read the detailed description
Naïve patients ≥ 18 years of age with histological confirmation of locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with an activating EGFR mutation and concomitant T790M mutation. Evidence of measurable or evaluable metastatic disease is required.
Primary objective:
- To evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria.
Secondary objectives:
- To determine the safety and tolerability profile of osimertinib (AZD9291), measured using the number and severity of AEs entered into the Case Report Form (CRF); chemistry, blood count, vital signs, physical examination, weight, ECG and performance status (S).
- To determine other efficacy parameters such as progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF), duration of response (DOR), disease control rate (DCR), and tumor shrinkage (TS).
- To correlate the parameters of clinical response efficacy documented with the EGFR mutational status.
- To carry out a longitudinal analysis of EGFR mutations (including the T790M mutation) in plasma and serum.
- To determine levels of BIM mRNA as well as mRNA levels of other biomarkers related to EGFR TKI response and determine whether they are predictors of treatment response.
- To identify mechanisms of acquired resistance to osimertinib (AZD9291); mutations at the site of covalent binding to the drug (C797) or other mutations in tissue or blood.
Type of study: Multicenter, international, single-arm, open-label, non-controlled phase IIa clinical study.
Treatment: Patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called AZD9291
The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib | Experimental | The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Defined as the percentage of patients who achieved complete response [CR] and partial response [PR] to treatment in accordance to the revised RECIST guidelines (version 1.1) for target lesions: CR, disappearance of all target lesions; PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Through study completion. From baseline up to approximately 28 months.
Secondary outcomes (13)
Overall Survival (OS)
Time from the start of treatment to the time of death due to any cause.
Measured: Through study completion. From baseline up to 41 months.
Duration of Response (DoR)
Time from the first documented response to documented disease progression or death, in accordance with RECIST 1.1 criteria.
Measured: Through study completion. From baseline up to 41 months.
Disease Control Rate
Percentage of patients with complete response, partial response or stable disease for a minimum of 24 weeks, assessed in accordance with the modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, during all study period from baseline up to 78 weeks from the time of the first administration dose
Measured: Through study completion. From baseline up to 41 months.
Tumor Shrinkage
Number of patients that presented tumor shrinkage
Measured: Through study completion. From baseline up to 41 months.
Overall Plasma EGFR Mutation Status at Baseline
Percentage of patients with a positive sensitizing EGFR mutation in plasma at baseline
Measured: Baseline
Overall Plasma Acquired Resistance to Osimertinib (AZD9291)
Percentage of patients who develop anti-drug mutations in plasma
Measured: Through study completion. From baseline up to 41 months.
Number of Participants With Grade 3 or 4 Adverse Events and SAEs
Patient safety and adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) of the U.S. National Cancer Institute (NCI), version 4. Adverse event(s) are those which, according to the protocol or in the opinion of the investigator, can cause serious or permanent damage or which rule out further treatment with the study drug. Grade 3 means severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 means life-threatening consequences; urgent intervention indicated.
Measured: Through study completion. From baseline up to 41 months.
Progression-free Survival
Defined as the period of time from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1.
Measured: Through study completion. From baseline up to 41 months.
Overall Plasma EGFR Mutation Status at Two Weeks After the First Study Dose
Measured by percentage of patients with a positive sensitizing EGFR mutation in plasma two weeks after the first study dose
Measured: Two weeks after the first study dose
Overall Plasma EGFR Mutation Status at Disease Progression
Measured by percentage of patients with a positive sensitizing EGFR mutation in plasma at disease progression
Measured: At the time of disease progression confirmed radiologically or clinically, up to 78 weeks
Plasma EGFR Thr790Met Mutation Status at Baseline
Measured by percentage of patients with EGFR Thr790Met mutation in plasma at baseline
Measured: At baseline
Plasma EGFR Thr790Met Mutation Status at Two Weeks After the First Study Dose
Measured by percentage of patients with EGFR Thr790Met mutation in plasma at two weeks after the first study dose
Measured: Two weeks after the first study dose
Plasma EGFR Thr790Met Mutation Status at Disease Progression
Measured by percentage of patients with EGFR Thr790Met mutation in plasma at disease progression
Measured: At the time of disease progression confirmed radiologically or clinically, up to 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start2 Sep 2016
- Primary completionDec 2018
- Study completion14 Feb 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Rafael Rosell, MD, PhD, Principal investigator, Catalan Institute of Oncology, Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841579
- Sponsor's protocol ID
- MedOPP112
- Other IDs
- 2015-004828-66, 2015
- Acronym
- AZENT
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2016
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Majem M, Sullivan I, Viteri S, Lopez-Vivanco G, Cobo M, Sanchez JM, Garcia-Gonzalez J, Garde J, Sampayo M, Martrat G, Malfettone A, Karachaliou N, Molina-Vila MA, Rosell R. First-line osimertinib in patients with epidermal growth factor receptor-mutant non-small-cell lung cancer and with a coexisting low allelic fraction of Thr790Met. Eur J Cancer. 2021 Dec;159:174-181. doi: 10.1016/j.ejca.2021.09.039. Epub 2021 Nov 8.
PubMed 34763195
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Clinical Trial to Evaluate the Safety and Efficacy of Osimertinib (AZD9291) in First-line Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC and Concomitant EGFR T790M Mutation at Time of Diagnosis
- ClinicalTrials.gov ID
- NCT02841579
- Acronym / sponsor ID
- AZENT / MedOPP112
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 2 Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal is to evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria.
Safety and efficacy will also be measured.
Detailed description
Naïve patients ≥ 18 years of age with histological confirmation of locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with an activating EGFR mutation and concomitant T790M mutation. Evidence of measurable or evaluable metastatic disease is required.
Primary objective:
- To evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria.
Secondary objectives:
- To determine the safety and tolerability profile of osimertinib (AZD9291), measured using the number and severity of AEs entered into the Case Report Form (CRF); chemistry, blood count, vital signs, physical examination, weight, ECG and performance status (S).
- To determine other efficacy parameters such as progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF), duration of response (DOR), disease control rate (DCR), and tumor shrinkage (TS).
- To correlate the parameters of clinical response efficacy documented with the EGFR mutational status.
- To carry out a longitudinal analysis of EGFR mutations (including the T790M mutation) in plasma and serum.
- To determine levels of BIM mRNA as well as mRNA levels of other biomarkers related to EGFR TKI response and determine whether they are predictors of treatment response.
- To identify mechanisms of acquired resistance to osimertinib (AZD9291); mutations at the site of covalent binding to the drug (C797) or other mutations in tissue or blood.
Type of study: Multicenter, international, single-arm, open-label, non-controlled phase IIa clinical study.
Treatment: Patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osimertinib | Experimental | Drug: OsimertinibThe patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily. Patients will receive study treatment until disease progression or occurrence of unacceptable side effects up to 78 weeks from the time of the first administered dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient aged 18 years or older
- Patients with histological confirmation of locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with an activating EGFR mutation and concomitant T790M mutation who are not candidates for local curative treatment.
- Patients with a M1a stage according to the TNM version 7 including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease that is not a candidate for curative treatment (including patients who progress after chemoradiotherapy in stage III disease).
- Patients with a EGFR deletion or mutation in exon 19, exon 21 (L858R, L861Q) or exon 18 (G719X) and concomitant T790M mutation before treatment confirmed centrally.
- ECOG (Eastern Cooperative Oncology Group) performance status less than or equal to 2.
Key exclusion criteria (21 listed)
- Locally advanced lung cancer candidate for curative treatment through radical surgery and/or radio(chemo)therapy.
- Patients diagnosed with another lung cancer subtype, patients with mixed NSCLC with predominantly squamous cell cancer, or with any small-cell lung cancer component.
- Patients with a EGFR deletion or mutation in exon 19, exon 21 (L858R, L861Q) or exon 18 (G719X) and concomitant T790M mutation before treatment that have not been confirmed centrally.
- Patients who have received prior antineoplastic treatment for advanced disease.
- Second active neoplasia
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 |
|---|---|---|
| OsimertinibAlso: AZD9291The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose. | Drug | Osimertinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: Through study completion. From baseline up to approximately 28 months.
Defined as the percentage of patients who achieved complete response [CR] and partial response [PR] to treatment in accordance to the revised RECIST guidelines (version 1.1) for target lesions: CR, disappearance of all target lesions; PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
13 secondary outcomes
Overall Survival (OS)
Time frame: Through study completion. From baseline up to 41 months.
Duration of Response (DoR)
Time frame: Through study completion. From baseline up to 41 months.
Disease Control Rate
Time frame: Through study completion. From baseline up to 41 months.
Tumor Shrinkage
Time frame: Through study completion. From baseline up to 41 months.
Overall Plasma EGFR Mutation Status at Baseline
Time frame: Baseline
Overall Plasma Acquired Resistance to Osimertinib (AZD9291)
Time frame: Through study completion. From baseline up to 41 months.
Number of Participants With Grade 3 or 4 Adverse Events and SAEs
Time frame: Through study completion. From baseline up to 41 months.
Progression-free Survival
Time frame: Through study completion. From baseline up to 41 months.
Overall Plasma EGFR Mutation Status at Two Weeks After the First Study Dose
Time frame: Two weeks after the first study dose
Overall Plasma EGFR Mutation Status at Disease Progression
Time frame: At the time of disease progression confirmed radiologically or clinically, up to 78 weeks
Plasma EGFR Thr790Met Mutation Status at Baseline
Time frame: At baseline
Plasma EGFR Thr790Met Mutation Status at Two Weeks After the First Study Dose
Time frame: Two weeks after the first study dose
Plasma EGFR Thr790Met Mutation Status at Disease Progression
Time frame: At the time of disease progression confirmed radiologically or clinically, up to 78 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34763195Majem M, Sullivan I, Viteri S, Lopez-Vivanco G, Cobo M, Sanchez JM, Garcia-Gonzalez J, Garde J, Sampayo M, Martrat G, Malfettone A, Karachaliou N, Molina-Vila MA, Rosell R. First-line osimertinib in patients with epidermal growth factor receptor-mutant non-small-cell lung cancer and with a coexisting low allelic fraction of Thr790Met. Eur J Cancer. 2021 Dec;159:174-181. doi: 10.1016/j.ejca.2021.09.039. Epub 2021 Nov 8.
- Individual participant dataSharing planned: No
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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.
Rafael Rosell, MD, PhD principal investigator
Catalan Institute of Oncology, Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osimertinib in people with Non-Small Cell Lung Cancer, run by MedSIR at 7 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 20 inclusion and 21 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 28 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 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 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?
Objective Response Rate (ORR) (time frame: Through study completion. From baseline up to approximately 28 months.). 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 NCT02841579, which also lists 1 linked publication.
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 28 Jan 2025.