Non-small Cell Lung CancerPhase 2DUARTNCT04249362
Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy
A Phase 2 study testing Durvalumab in people with Non-small Cell Lung Cancer, run by AstraZeneca at 35 sites in 6 countries.
Trial summary
This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 35 sitesin 6 countries
- Study dates
- 26 Nov 2020to 25 Nov 2024
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent.
- Age ≥ 18 years at study entry.
- Histologically or cytologically documented NSCLC with locally-advanced, unresectable Stage III disease.
- Deemed ineligible for chemotherapy per Investigator assessment.
- Receipt of radiation therapy that was completed within 42 days prior to first study drug administration.
- Must have received a total dose of radiation of 40 to 66 Gy (standard or hypofractionated BED).
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- Must not have progressed following radiation therapy, as per Investigator assessed RECIST 1.1 criteria: a) Patients with measurable disease and/or nonmeasurable and/or no evidence of disease assessed at baseline by computed tomography /magnetic resonance imaging will be eligible for this study. b) Prior irradiated lesions may be considered measurable and selected as target lesions (TLs) providing they fulfill the other criteria for measurability.
- World Health Organization/ECOG performance status of ≤2.
- No prior exposure to immune-mediated therapy including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and antiprogrammed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
- Patients must have adequate organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1.0 × 109 /L
- Platelet count ≥ 75 × 109/L
- Serum bilirubin ≤ 1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome.
- Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × ULN
- Measured creatinine clearance > 30 mL/min or calculated CL > 30 mL/min as determined by Cockcroft-Gault
- Life expectancy of greater than 12 weeks.
- Body weight greater than 30 kg at study entry and at first study drug administration
Who cannot join
- Patients with locally-advanced NSCLC whose disease has progressed following radiation therapy.
- Mixed small cell lung cancer and NSCLC histology.
- History of allogeneic organ transplantation.
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome).
- Uncontrolled intercurrent illness (e.g., ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris)
- History of another primary malignancy except for (a) malignancy treated with curative intent and with no known active disease ≥ 5 years before the first study drug administration, (b) adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease, and c) treated carcinoma in situ without evidence of disease.
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- History of leptomeningeal carcinomatosis
- History of active primary immunodeficiency
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
- Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia, and the laboratory values defined in the inclusion criteria
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
- Participation in another clinical study with an IP administered in the last 4 weeks.
- Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study
- Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
- Patients who refuse chemotherapy by their own decision.
- Involvement in the planning and/or conduct of the study
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.
- Judgment by the Investigator that the patient should not participate in the study
- Genetics research study (optional):
- Exclusion criteria for participation in the optional genetics research component of the study include: a) Previous allogeneic bone marrow transplant b)Nonleukocyte-depleted whole blood transfusion within 120 days of genetic sample collection.
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
Italy12 sites
Research Site
Brescia, 25100
Research Site
Florence, 50134
Research Site
Genova, 16132
Research Site
Meldola, 47014
Research Site
Messina, 98158
Research Site
Modena, 41124
Research Site
Monza, 20900
Research Site
Negrar, 37024
Research Site
Pavia, 27100
Research Site
Pisa, 56124
Research Site
Ravenna, 48121
Research Site
Roma, 00128
Spain7 sites
Research Site
A Coruña, 15006
Research Site
Barcelona, 8035
Research Site
Castellon, 12002
Research Site
Madrid, 28050
Research Site
Oviedo, 33011
Research Site
Pamplona, 31008
Research Site
Sabadell(Barcelona), 08208
France5 sites
Research Site
Limoges, 87000
Research Site
Marseille, 13009
Research Site
Montpellier, 34070
Research Site
Nîmes, 30029
Research Site
Rouen, 76031
Poland5 sites
Research Site
Bialystok, 15-044
Research Site
Gdansk, 80-214
Research Site
Olsztyn, 10-228
Research Site
Szczecin, 71-730
Research Site
Warsaw, 02-781
United States3 sites
Research Site
Royal Oak, Michigan, 48073
Research Site
Tampa, Florida, 33612
Research Site
Tucson, Arizona, 85704
Russia3 sites
Research Site
Saint Petersburg, 197002
Research Site
Saint Petersburg, 197758
Research Site
Ufa, 450054
About this study
Official title: A Phase II, Open-label, Multicenter, International Study of Durvalumab Following Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer Who Are Ineligible for Chemotherapy
This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative radiation therapy [40 to < 54 Gy or hypofractionated BED])
Read the detailed description
This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who have an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and who were treated with radiotherapy but are ineligible for chemotherapy. Patients will be enrolled into 2 cohorts according to the dose of radiotherapy received prior to study entry (Cohort A: Standard Radiotherapy [60 Gy ± 10% or hypofractionated BED]; Cohort B: Palliative Radiotherapy [40 to < 54 Gy or hypofractionated BED]). Patients must not have progressed following radiation therapy, and radiation therapy must be completed within 6 weeks (42 days) prior to first study drug administration. The last dose of radiation therapy is defined as the day of the last radiation treatment session. All patients will receive 1500 mg durvalumab via IV infusion every 4 weeks (q4w) for up to a maximum of 12 months (up to 13 doses/cycles)
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Durvalumab
- Keywords
- Radiation therapy, Phase II, Palliative Radiotherapy
- 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.
DurvalumabDrug
Also called MEDI4736
All patients will receive 1500 mg durvalumab via IV infusion q4w for up to a maximum of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Patients received standard radiotherapy [60 gray (Gy) ± 10% or hypofractionated BED] prior to study entry. Receives: Drug: Durvalumab |
| Cohort B | Experimental | Patients received palliative radiotherapy [40 to < 54 Gy or hypofractionated BED] prior to study entry. Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs)
The safety and tolerability profile of durvalumab as defined by Grade 3 and Grade 4 PRAEs within 6 months from the initiation of durvalumab treatment. A PRAE was any TEAE with a possible relatedness to durvalumab, or where the relatedness was missing. If relatedness of a TEAE was missing at the primary DCO (30 March 2023) the TEAE was considered a PRAE.
Measured: From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment
Secondary outcomes (11)
Median Progression-free Survival (mPFS)
Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits.
Measured: From the first date of treatment until the date of objective disease progression or death or data cut-off date (36 months)
Progression-free Survival at 6 Months (PFS6)
Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits.
Measured: From the first date of treatment until the date of objective disease progression or death (6 months)
Progression-free Survival at 12 Months (PFS12)
Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits.
Measured: From the first date of treatment until the date of objective disease progression or death (12 months)
Median Overall Survival (mOS)
The OS is defined as the time from the date of first dose of durvalumab until death due to any cause. Patients who were not known to have died at the time of analysis were censored at the last recorded date when they were known to have been alive.
Measured: From the first date of treatment until death or data cut-off due to any cause (36 months)
Overall Survival at 12 Months (OS12)
The OS is defined as the time from the date of first dose of durvalumab until death due to any cause. Patients who were not known to have died at the time of analysis were censored at the last recorded date when they were known to have been alive.
Measured: From the first date of treatment until death due to any cause (12 months)
Objective Response Rate (ORR)
The ORR is the proportion (%) of patients with an overall response of complete response (CR) or partial response (PR) (confirmed by a follow-up scan at least 4 weeks after showing CR or PR) per RECIST 1.1 criteria. CR is disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to < 10 mm. PR is at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Measured: From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months)
Duration of Response (DoR)
The DoR is defined as the time from the date of first documented response (which is subsequently confirmed) until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.
Measured: From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months)
Lung Cancer Mortality
The lung cancer mortality (NSCLC-related death) is assessed using the deaths which are reported as 'NSCLC-related' and is defined as the time (days) from the date of first dose of durvalumab until date of death due to lung cancer.
Measured: From date of treatment start until death due to lung cancer (36 months)
Number of Patients With Events (AEs)
The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed.
Measured: From screening (Day -28) till data cut-off (36 months)
Number of Patients With Adverse Events of Special Interests (AESIs)
The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An AESI is an AE of scientific and medical interest specific to the understanding of durvalumab. AESIs for durvalumab include, but are not limited to, events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy. Here, number of patients experienced AESIs are presented. Serious adverse event of special interests (SAESIs).
Measured: From screening (Day -28) till data cut-off (36 months)
Number of Patients With Immune-mediated Adverse Events (imAEs)
The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An imAE is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action and where there is no clear alternate etiology. Here, number of patients experienced imAEs are presented. Immune-mediated serious adverse events (imSAEs)
Measured: From screening (Day -28) till data cut-off (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start26 Nov 2020
- Primary completion30 Mar 2023
- Study completion25 Nov 2024
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Andrea Riccardo Filippi, Principal investigator, Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249362
- Sponsor's protocol ID
- D4194C00009
- Other IDs
- 2019-004336-31, 2019
- Acronym
- DUART
- Status last verified
- Dec 2024
- First submitted
- 29 Jan 2020
- Last updated
- 10 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Filippi AR, Dziadziuszko R, Garcia Campelo MR, Paoli JB, Sawyer W, Diaz Perez IE. DUART: durvalumab after radiotherapy in patients with unresectable, stage III NSCLC who are ineligible for chemotherapy. Future Oncol. 2021 Dec;17(34):4657-4663. doi: 10.2217/fon-2021-0952. Epub 2021 Nov 15.
PubMed 34775804
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Multicenter, International Study of Durvalumab Following Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer Who Are Ineligible for Chemotherapy
- ClinicalTrials.gov ID
- NCT04249362
- Acronym / sponsor ID
- DUART / D4194C00009
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Radiation therapy, Phase II, Palliative Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 25 Sep 2024
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 II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative radiation therapy [40 to < 54 Gy or hypofractionated BED])
Detailed description
This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who have an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and who were treated with radiotherapy but are ineligible for chemotherapy. Patients will be enrolled into 2 cohorts according to the dose of radiotherapy received prior to study entry (Cohort A: Standard Radiotherapy [60 Gy ± 10% or hypofractionated BED]; Cohort B: Palliative Radiotherapy [40 to < 54 Gy or hypofractionated BED]). Patients must not have progressed following radiation therapy, and radiation therapy must be completed within 6 weeks (42 days) prior to first study drug administration. The last dose of radiation therapy is defined as the day of the last radiation treatment session. All patients will receive 1500 mg durvalumab via IV infusion every 4 weeks (q4w) for up to a maximum of 12 months (up to 13 doses/cycles)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: DurvalumabPatients received standard radiotherapy [60 gray (Gy) ± 10% or hypofractionated BED] prior to study entry. |
| Cohort B | Experimental | Drug: DurvalumabPatients received palliative radiotherapy [40 to < 54 Gy or hypofractionated BED] prior to study entry. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Capable of giving signed informed consent.
- Age ≥ 18 years at study entry.
- Histologically or cytologically documented NSCLC with locally-advanced, unresectable Stage III disease.
- Deemed ineligible for chemotherapy per Investigator assessment.
- Receipt of radiation therapy that was completed within 42 days prior to first study drug administration.
Key exclusion criteria (23 listed)
- Patients with locally-advanced NSCLC whose disease has progressed following radiation therapy.
- Mixed small cell lung cancer and NSCLC histology.
- History of allogeneic organ transplantation.
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome).
- Uncontrolled intercurrent illness (e.g., ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris)
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 |
|---|---|---|
| DurvalumabAlso: MEDI4736All patients will receive 1500 mg durvalumab via IV infusion q4w for up to a maximum of 12 months. | Drug | Cohort A, Cohort B |
Primary outcome
Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs)
Time frame: From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment
The safety and tolerability profile of durvalumab as defined by Grade 3 and Grade 4 PRAEs within 6 months from the initiation of durvalumab treatment. A PRAE was any TEAE with a possible relatedness to durvalumab, or where the relatedness was missing. If relatedness of a TEAE was missing at the primary DCO (30 March 2023) the TEAE was considered a PRAE.
11 secondary outcomes
Median Progression-free Survival (mPFS)
Time frame: From the first date of treatment until the date of objective disease progression or death or data cut-off date (36 months)
Progression-free Survival at 6 Months (PFS6)
Time frame: From the first date of treatment until the date of objective disease progression or death (6 months)
Progression-free Survival at 12 Months (PFS12)
Time frame: From the first date of treatment until the date of objective disease progression or death (12 months)
Median Overall Survival (mOS)
Time frame: From the first date of treatment until death or data cut-off due to any cause (36 months)
Overall Survival at 12 Months (OS12)
Time frame: From the first date of treatment until death due to any cause (12 months)
Objective Response Rate (ORR)
Time frame: From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months)
Duration of Response (DoR)
Time frame: From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months)
Lung Cancer Mortality
Time frame: From date of treatment start until death due to lung cancer (36 months)
Number of Patients With Events (AEs)
Time frame: From screening (Day -28) till data cut-off (36 months)
Number of Patients With Adverse Events of Special Interests (AESIs)
Time frame: From screening (Day -28) till data cut-off (36 months)
Number of Patients With Immune-mediated Adverse Events (imAEs)
Time frame: From screening (Day -28) till data cut-off (36 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34775804Filippi AR, Dziadziuszko R, Garcia Campelo MR, Paoli JB, Sawyer W, Diaz Perez IE. DUART: durvalumab after radiotherapy in patients with unresectable, stage III NSCLC who are ineligible for chemotherapy. Future Oncol. 2021 Dec;17(34):4657-4663. doi: 10.2217/fon-2021-0952. Epub 2021 Nov 15.
- CSP RedactedLink provided by the sponsor.
- SAP RedactedLink provided by the sponsor.
- CSR synopsis RedactedLink 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Dr Andrea Riccardo Filippi principal investigator
Fondazione IRCCS Policlinico San Matteo
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab in people with Non-small Cell Lung Cancer, run by AstraZeneca at 35 sites in 6 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 18 inclusion and 23 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 10 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 35 sites in Italy, Spain, France, Poland, United States and 1 more country. 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 25 Sep 2024). 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 Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs) (time frame: From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment). 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 NCT04249362, 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 10 Jan 2025.