Trial · NCT02453282
Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
NCT02453282, Phase 3, Active not recruiting, AstraZeneca; results first posted 2019-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC). Trials, record NCT02453282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02453282
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
- NCT number
- NCT02453282
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,118 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Non-Small-Cell Lung Carcinoma NSCLC
- Interventions
- MEDI4736 (Durvalumab), MEDI4736 (Durvalumab)+Tremelimumab, Paclitaxel + Carboplatin, Gemcitabine + Cisplatin, Gemcitabine + Carboplatin, Pemetrexed + Cisplatin, Pemetrexed + Carboplatin, Tremelimumab
- First posted
- 2015-05-25
- Last updated
- 2026-08-06
- Other registries' IDs
- eudract:2015-001279-39
- Results first posted
- 2019-11-29
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. |
| Primary | Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of at least 5 millimeter (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. |
| Secondary | OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy | From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. |
| Secondary | OS; PD-L1 (TC >=1%) Analysis Set Population | From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. |
| Secondary | OS; FAS Population | From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). | The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique. |
| Secondary | PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. |
| Secondary | PFS; PD-L1 (TC >=1%) Analysis Set Population | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. |
| Secondary | PFS; FAS Population | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique. |
| Secondary | Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of Complete Response (CR) or Partial Response (PR). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). |
| Secondary | ORR; PD-L1 (TC >=1%) Analysis Set Population | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met). |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). | The PD-L1 (TC \>=25%) analysis set included subset of participants in the FAS whose PD-L1 status was PD-L1 (TC \>=25%) as defined by Ventana PD-L1 (SP263) assay (ie, \>=25% TCs expressing PD-L1 on the membrane). Comparison of durvalumab monotherapy Vs SoC and durvalumab + tremelimumab Vs SoC reporting groups were analysed for primary outcome measure. | months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The PD-L1 (TC \>=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC \>=25%) as defined by the Ventana PD-L1 (SP263) assay (ie, \>=25% TCs expressing PD-L1 on the membrane). Comparison of durvalumab + tremelimumab Vs SoC chemotherapy reporting groups were analysed for the primary outcome measure. | months | MEDIAN |
| SECONDARY | OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy | From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). | The PD-L1 (TC \>=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC \>=25%) as defined by the Ventana PD-L1 (SP263) assay (ie, \>=25% TCs expressing PD-L1 on the membrane). Comparison of durvalumab + tremelimumab Vs durvalumab monotherapy reporting groups were analysed for the secondary outcome measure. | months | MEDIAN |
| SECONDARY | OS; PD-L1 (TC >=1%) Analysis Set Population | From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). | The PD-L1 (TC \>=1%) analysis set included the subset of participants in the FAS whose PD-L1 status is PD-L1 (TC \>=1%) as defined by the Ventana PD-L1 (SP263) assay (ie, \>=1% TC expressing PD-L1 on the membrane). | months | MEDIAN |
| SECONDARY | OS; FAS Population | From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). | The FAS included all randomized participants analyzed on an ITT basis. | months | MEDIAN |
| SECONDARY | PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The PD-L1 (TC \>=25%) analysis set included subset of participants in the FAS whose PD-L1 status was PD-L1 (TC \>=25%) as defined by Ventana PD-L1 (SP263) assay (ie, \>=25% TCs expressing PD-L1 on the membrane). Comparison of durvalumab + tremelimumab Vs durvalumab and durvalumab Vs SoC reporting groups were analysed for secondary outcome measure. | months | MEDIAN |
| SECONDARY | PFS; PD-L1 (TC >=1%) Analysis Set Population | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The PD-L1 (TC \>=1%) analysis set included the subset of participants in the FAS whose PD-L1 status is PD-L1 (TC \>=1%) as defined by the Ventana PD-L1 (SP263) assay (ie, \>=1% TC expressing PD-L1 on the membrane). | months | MEDIAN |
| SECONDARY | PFS; FAS Population | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The FAS included all randomized participants analyzed on an ITT basis. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The PD-L1 (TC \>=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC \>=25%) as defined by the Ventana PD-L1 (SP263) assay (ie, \>=25% TC expressing PD-L1 on the membrane). | percentage of participants | NUMBER |
| SECONDARY | ORR; PD-L1 (TC >=1%) Analysis Set Population | Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | The PD-L1 (TC \>=1%) analysis set included the subset of participants in the FAS whose PD-L1 status is PD-L1 (TC \>=1%) as defined by the Ventana PD-L1 (SP263) assay (ie, \>=1% TC expressing PD-L1 on the membrane). | percentage of participants | NUMBER |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy | Durvalumab Monotherapy | 16.3 | 95% Confidence Interval 12.2 to 20.8 | months | |
| Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy | Durvalumab + Tremelimumab | 11.9 | 95% Confidence Interval 9.0 to 17.7 | months | |
| Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy | SoC Chemotherapy | 12.9 | 95% Confidence Interval 10.5 to 15.0 | months | |
| Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy | Durvalumab + Tremelimumab | 3.9 | 95% Confidence Interval 2.8 to 5.0 | months | |
| Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy | SoC Chemotherapy | 5.4 | 95% Confidence Interval 4.6 to 5.8 | months | |
| OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy | Durvalumab Monotherapy | 16.3 | 95% Confidence Interval 12.2 to 20.8 | months | |
| OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy | Durvalumab + Tremelimumab | 11.9 | 95% Confidence Interval 9.0 to 17.7 | months | |
| OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy | SoC Chemotherapy | 12.9 | 95% Confidence Interval 10.5 to 15.0 | months | |
| OS; PD-L1 (TC >=1%) Analysis Set Population | Durvalumab Monotherapy | 14.6 | 95% Confidence Interval 10.5 to 17.7 | months | |
| OS; PD-L1 (TC >=1%) Analysis Set Population | Durvalumab + Tremelimumab | 10.9 | 95% Confidence Interval 9.1 to 13.5 | months |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Durvalumab Monotherapy | 374 | |
| Overall Study | STARTED | Durvalumab + Tremelimumab | 372 | |
| Overall Study | STARTED | SoC Chemotherapy | 372 | |
| Overall Study | Received Treatment | Durvalumab Monotherapy | 369 | |
| Overall Study | Received Treatment | Durvalumab + Tremelimumab | 371 | |
| Overall Study | Received Treatment | SoC Chemotherapy | 352 | |
| Overall Study | COMPLETED | Durvalumab Monotherapy | 0 | |
| Overall Study | COMPLETED | Durvalumab + Tremelimumab | 0 | |
| Overall Study | COMPLETED | SoC Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Durvalumab Monotherapy | 374 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events3,465
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Durvalumab Monotherapy | 36 | 369 | 37 |
| other | Anaemia | Blood and lymphatic system disorders | Durvalumab + Tremelimumab | 33 | 371 | 39 |
| other | Anaemia | Blood and lymphatic system disorders | SoC Chemotherapy | 136 | 352 | 177 |
| other | Bone marrow failure | Blood and lymphatic system disorders | Durvalumab Monotherapy | 0 | 369 | 0 |
| other | Bone marrow failure | Blood and lymphatic system disorders | Durvalumab + Tremelimumab | 0 | 371 | 0 |
| other | Bone marrow failure | Blood and lymphatic system disorders | SoC Chemotherapy | 1 | 352 | 2 |
| other | Coagulopathy | Blood and lymphatic system disorders | Durvalumab Monotherapy | 1 | 369 | 1 |
| other | Coagulopathy | Blood and lymphatic system disorders | Durvalumab + Tremelimumab | 0 | 371 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | SoC Chemotherapy | 0 | 352 | 0 |
| other | Cytopenia | Blood and lymphatic system disorders | Durvalumab Monotherapy | 0 | 369 | 0 |
1 to 10 of 3,465Source ClinicalTrials.gov
See all 3,465 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Durvalumab Monotherapy | 278 | 374 |
| Total, all-cause mortality | Durvalumab + Tremelimumab | 278 | 372 |
| Total, all-cause mortality | SoC Chemotherapy | 297 | 372 |
| Total, other adverse events | Durvalumab Monotherapy | 335 | 369 |
| Total, other adverse events | Durvalumab + Tremelimumab | 328 | 371 |
| Total, other adverse events | SoC Chemotherapy | 332 | 352 |
| Total, serious adverse events | Durvalumab Monotherapy | 131 | 369 |
| Total, serious adverse events | Durvalumab + Tremelimumab | 178 | 371 |
| Total, serious adverse events | SoC Chemotherapy | 112 | 352 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02453282
GET https://conductscience.org/api/trials/v1/NCT02453282/registered?page=2