CancerPhase 2DARTNCT04392505
Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study
A Phase 2 study testing Durvalumab Injection in people with Cancer and Non Small Cell Lung Cancer, run by Oslo University Hospital at 10 sites in 4 countries.
Trial summary
The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage III
- What is being tested?
- Durvalumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 11 May 2020to 1 May 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Locally-advanced, unresectable, stage III NSCLC (including PET-CT and MRI-brain in the diagnostic work-up).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Diagnostic biopsy with PD-L1 <1% in 50 patients PD-L1 ≥1% in 50 patients
- Adequate core or excisional biopsy for tumor assessment
- Age > 18 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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- Life expectancy of at least 12 weeks
- Body weight >30 kg
- Adequate normal organ and marrow function as defined below:
- Haemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) 1.5 x (> 1500 per mm3)
- Platelet count ≥100 x 109/L (>75,000 per mm3)
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).
- AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
- Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- Males:
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
- Females:
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
- Women of childbearing potential (WOCBP) should have a negative urine or serum pregnancy within 7 days prior to receiving the firs dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A woman is considered as WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- WOCBP should use an adequate method to avoid pregnancy
- males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) / the time required for the investigational drug to undergo five half-lives
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Non-small cell lung cancer disease suitable for curative surgery
- Significant cardiac, pulmonary or other medical illness that would limit activity or survival
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study during the last 2 weeks.
- Any concurrent chemotherapy, Investigational Product (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- History of allogenic organ transplantation.
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- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stableon hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent j. History of another primary malignancy except for
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease k. History of active primary immunodeficiency or medical condition requiring high doses (>30 mg prednisolone daily) of systemic steroids or other forms of immunosuppressive therapy l. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), and hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
- Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
- Patients with grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study physician.
- Patients with irreverible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consulation with the Study Physician.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Norway5 sites
Haukeland universitetssykehus
Bergen
Oslo University Hospital
Oslo
Stavanger University Hospital
Stavanger
Universitetssykehuset i Nord-Norge
Tromsø
St. Olavs Hospital
Trondheim
Finland3 sites
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere, 33520
Turku University Hospital
Turku
About this study
Official title: Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC Patients - a Phase II Translational and Biomarker Study Investigating PDL1 Positive and Negative Patients
The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation.
The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.
Read the detailed description
This is an open, multinational, phase 2 trial to investigate the Properties of cancer cells before, during and after treatment with the investigational study drug durvalumab in patients with locally advanced non-small celled lung cancer (NSCLC). Both patients with high and low PD-L1 expression are allowed to participate. Durvalumab (PD-L1 inhibitor) will be administered after a period with standardtreatment with chemotherapy and radiationtherapy (chemoradiotherapy) for around 7 weeks. After maximum 5 weeks break after chemoradiotherapy, durvalumab will be given in the same dose to all patients for up to 12 months. The follow-up include a safety follow-up for up to five years, followed by a survival follow-up for up to a total of ten years.
The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation.
The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.
- Conditions
- Cancer, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage III, NSCLC, NSCLC, Stage III
- Being tested
- Durvalumab Injection
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab InjectionDrug
Also called Imfinzi
Included patients will receive durvalumab (fixed dose, 1500mg Q4W) until progressive disease and no clinical benefit, intolerable toxicity or patient's wish, for a maximum duration of 12 months. Treatment with durvalumab should start <5 weeks after last radiotherapy dosing.
| Study group | Role | What they receive |
|---|---|---|
| The whole study population | Experimental | All patients will receive durvalumab for up to 1 months after standard treatment With chemoradiotherapy. Receives: Drug: Durvalumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of tumour mutational burden (TMB) measured in the tumour tissue and blood samples, on the hazard.
Analyses of TMB in tumour tissue. Patients with high Tumour Mutational Burden, TMB (> 8.5 mutations per megabase) have a hazard ratio equal to or less than 0.55 as compared to patients with low TMB. Tumor tissue will be analysed in regard to TMB, and several different cut-offs will be evaluated.
Measured: Throughout study, up to 5 years
Secondary outcomes (7)
Predict assosiation between Tumour Mutational Burden, TMB, measured in tumour tissue and blood samples and clinical response
To investigate different levels of TMB in tumor tissue compared to blood samples, as predictors for development of clinical response
Measured: Through study, up to 5 years
Specific RNA profiles predict response to treatment
Transcriptome characterization (RNA-sequencing) on tumour material to investigate this
Measured: Through study, up to 5 years
Impact of Molecular profiles in urine on response to treatment
To investigate urine for predictive biomarkers (ctDNA, miRNA)
Measured: Through study, up to 5 years
Analysis of pre-treatment and under-treatment samples may identify biomarkers for predicting which patients will benefit from treatment with durvalumab after chemoradiation
Analyses of biomarkers in tumour tissue.
Measured: Through study, up to 5 years
The durvalumab treatment following chemoradiation will induce T cell responses against antigens expressed in each patient´s tumor.
Immunological response assessment performed on tumour material from participants.
Measured: Through study, up to 5 years
A possible change in PD-L1 status will be explored
Immunohistochemistry of PD-L1 assessed on tumour tissue.
Measured: Through study, up to 5 years
The durvalumab treatment following chemoradiation has acceptable safety and tolerability in NSCLC patients, as assessed by Patient Reported Outcome measurements.
Patient reported outcome measurements by standardized Tools; EORTC-QLQ-C30 and LC13.
Measured: Through study, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start11 May 2020
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open, exploratory, multinational, phase 2 trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Åslaug Helland, Oslo University Hospital
- Investigators
- Åslaug Helland, Prof, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392505
- Sponsor's protocol ID
- DART
- Acronym
- DART
- Status last verified
- Feb 2024
- First submitted
- 8 May 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Horndalsveen H, Haakensen VD, Madebo T, Gronberg BH, Halvorsen TO, Bjaanaes MM, Danielsen BK, Borve M, Kokkvoll S, Boda TSD, Ojlert AK, Helland A. ctDNA-Based MRD Detection in Stage III NSCLC Treated With Chemoradiotherapy and Durvalumab. J Thorac Oncol. 2026 Jun 23:103992. doi: 10.1016/j.jtho.2026.103992. Online ahead of print.
PubMed 42336205Horndalsveen H, Haakensen VD, Madebo T, Gronberg BH, Halvorsen TO, Koivunen J, Oselin K, Cicenas S, Helbekkmo N, Aanerud M, Ahvonen J, Silvoniemi M, Bjaanaes MM, Farooqi S, Nebdal D, Dalsgaard AM, Danielsen BK, Borve M, Dalen TS, Ojlert AK, Helland A. Blood-based tumor mutational burden as a biomarker in unresectable non-small cell lung cancer treated with chemoradiotherapy and durvalumab. Front Oncol. 2025 Oct 22;15:1681420. doi: 10.3389/fonc.2025.1681420. eCollection 2025.
PubMed 41199847Langberg CW, Horndalsveen H, Helland A, Haakensen VD. Factors associated with failure to start consolidation durvalumab after definitive chemoradiation for locally advanced NSCLC. Front Oncol. 2023 Jul 5;13:1217424. doi: 10.3389/fonc.2023.1217424. eCollection 2023.
PubMed 37476372
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC Patients - a Phase II Translational and Biomarker Study Investigating PDL1 Positive and Negative Patients
- ClinicalTrials.gov ID
- NCT04392505
- Acronym / sponsor ID
- DART / DART
- Conditions
- Cancer, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage III, NSCLC, NSCLC, Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 11 May 2020 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2033 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation.
The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.
Detailed description
This is an open, multinational, phase 2 trial to investigate the Properties of cancer cells before, during and after treatment with the investigational study drug durvalumab in patients with locally advanced non-small celled lung cancer (NSCLC). Both patients with high and low PD-L1 expression are allowed to participate. Durvalumab (PD-L1 inhibitor) will be administered after a period with standardtreatment with chemotherapy and radiationtherapy (chemoradiotherapy) for around 7 weeks. After maximum 5 weeks break after chemoradiotherapy, durvalumab will be given in the same dose to all patients for up to 12 months. The follow-up include a safety follow-up for up to five years, followed by a survival follow-up for up to a total of ten years.
The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation.
The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open, exploratory, multinational, phase 2 trial
| Arm | Type | Receives |
|---|---|---|
| The whole study population | Experimental | Drug: Durvalumab InjectionAll patients will receive durvalumab for up to 1 months after standard treatment With chemoradiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Locally-advanced, unresectable, stage III NSCLC (including PET-CT and MRI-brain in the diagnostic work-up).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Diagnostic biopsy with PD-L1 <1% in 50 patients PD-L1 ≥1% in 50 patients
- Adequate core or excisional biopsy for tumor assessment
- Age > 18 years at time of study entry
Key exclusion criteria (27 listed)
- Non-small cell lung cancer disease suitable for curative surgery
- Significant cardiac, pulmonary or other medical illness that would limit activity or survival
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study during the last 2 weeks.
- Any concurrent chemotherapy, Investigational Product (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
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 |
|---|---|---|
| Durvalumab InjectionAlso: ImfinziIncluded patients will receive durvalumab (fixed dose, 1500mg Q4W) until progressive disease and no clinical benefit, intolerable toxicity or patient's wish, for a maximum duration of 12 months. Treatment with durvalumab should start <5 weeks after last radiotherapy dosing. | Drug | The whole study population |
Primary outcome
Impact of tumour mutational burden (TMB) measured in the tumour tissue and blood samples, on the hazard.
Time frame: Throughout study, up to 5 years
Analyses of TMB in tumour tissue. Patients with high Tumour Mutational Burden, TMB (> 8.5 mutations per megabase) have a hazard ratio equal to or less than 0.55 as compared to patients with low TMB. Tumor tissue will be analysed in regard to TMB, and several different cut-offs will be evaluated.
7 secondary outcomes
Predict assosiation between Tumour Mutational Burden, TMB, measured in tumour tissue and blood samples and clinical response
Time frame: Through study, up to 5 years
Specific RNA profiles predict response to treatment
Time frame: Through study, up to 5 years
Impact of Molecular profiles in urine on response to treatment
Time frame: Through study, up to 5 years
Analysis of pre-treatment and under-treatment samples may identify biomarkers for predicting which patients will benefit from treatment with durvalumab after chemoradiation
Time frame: Through study, up to 5 years
The durvalumab treatment following chemoradiation will induce T cell responses against antigens expressed in each patient´s tumor.
Time frame: Through study, up to 5 years
A possible change in PD-L1 status will be explored
Time frame: Through study, up to 5 years
The durvalumab treatment following chemoradiation has acceptable safety and tolerability in NSCLC patients, as assessed by Patient Reported Outcome measurements.
Time frame: Through study, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 42336205Horndalsveen H, Haakensen VD, Madebo T, Gronberg BH, Halvorsen TO, Bjaanaes MM, Danielsen BK, Borve M, Kokkvoll S, Boda TSD, Ojlert AK, Helland A. ctDNA-Based MRD Detection in Stage III NSCLC Treated With Chemoradiotherapy and Durvalumab. J Thorac Oncol. 2026 Jun 23:103992. doi: 10.1016/j.jtho.2026.103992. Online ahead of print.
- Derived from this study: PubMed 41199847Horndalsveen H, Haakensen VD, Madebo T, Gronberg BH, Halvorsen TO, Koivunen J, Oselin K, Cicenas S, Helbekkmo N, Aanerud M, Ahvonen J, Silvoniemi M, Bjaanaes MM, Farooqi S, Nebdal D, Dalsgaard AM, Danielsen BK, Borve M, Dalen TS, Ojlert AK, Helland A. Blood-based tumor mutational burden as a biomarker in unresectable non-small cell lung cancer treated with chemoradiotherapy and durvalumab. Front Oncol. 2025 Oct 22;15:1681420. doi: 10.3389/fonc.2025.1681420. eCollection 2025.
- Derived from this study: PubMed 37476372Langberg CW, Horndalsveen H, Helland A, Haakensen VD. Factors associated with failure to start consolidation durvalumab after definitive chemoradiation for locally advanced NSCLC. Front Oncol. 2023 Jul 5;13:1217424. doi: 10.3389/fonc.2023.1217424. eCollection 2023.
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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.
Åslaug Helland, Prof, MD principal investigator
Oslo University Hospital
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab Injection in people with Cancer and Non Small Cell Lung Cancer, run by Oslo University Hospital at 10 sites in 4 countries.
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 24 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Norway, Finland, Estonia, Lithuania. 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?
This study is still under way. Results are not available in the source record yet.
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?
Impact of tumour mutational burden (TMB) measured in the tumour tissue and blood samples, on the hazard. (time frame: Throughout study, up to 5 years). 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 NCT04392505, which also lists 3 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 29 Feb 2024.