Trial · NCT02542293
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
NCT02542293, Phase 3, Active not recruiting, AstraZeneca; results first posted 2022-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE). Trials, record NCT02542293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02542293
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
- NCT number
- NCT02542293
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 953 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Non Small Cell Lung Carcinoma NSCLC
- Interventions
- Durvalumab +Tremelimumab, Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin, Pemetrexed + carboplatin
- First posted
- 2015-09-07
- Last updated
- 2026-08-06
- Other registries' IDs
- eudract:2015-002197-21
- Results first posted
- 2022-05-24
- Limitations and caveats
Analysis of the China cohort was performed to evaluate the consistency of efficacy and safety in Chinese participants with the global cohort in order to meet China health regulatory requirements and was not powered for a formal assessment of statistical significance.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months). | 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 was 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 | OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months). | 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 was 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; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months). | OS was defined as time from 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 time of analysis was censored based on last recorded date on which participant was known to be alive. bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb and bTMB \<20 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥16 mut/Mb, ≥12 mut/Mb and \<20 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay. PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). bTMB non-evaluable analysis set included the subset of participants in FAS whose bTMB status at baseline could not be determined by the GuardantOMNI CDx assay or whose sample was not available. tTMB analysis sets are defined same as the bTMB analysis sets. |
| Secondary | OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global or China cohort DCO dates, as applicable (a maximum of approximately 44 months) for each cohort. | The OS was defined as time from 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 was censored based on last recorded date on which participant was known to be alive. Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses. PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay. |
| Secondary | Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months). | The PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 \[RECIST 1.1\] using Investigator assessments) was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay. tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay. |
| Secondary | PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort. | PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective PD or death regardless of whether participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). PD-L1-negative analysis set included subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Global Cohort: FAS included all randomized participants prior to end of global recruitment. China Cohort: China FAS included all randomized participants in China cohort and were used for all China only efficacy analyses. PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included subset of participants in FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay. |
| Secondary | Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months). | The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) prior to PD. bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay. tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay. |
| Secondary | ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort. | The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD. PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses. PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay. |
| Secondary | Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months). | DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1). bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay. |
| Secondary | DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort. | DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1). PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months). | The bTMB ≥20 mut/Mb analysis set included the subset of participants in the FAS whose blood TMB status was ≥20 mut/Mb at baseline as defined by the GuardantOMNI CDx assay. Only participants randomized in Global cohort were analyzed as bTMB and tissue tumor mutational burden (tTMB) testing was not performed in China cohort. | months | MEDIAN |
| PRIMARY | OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months). | The China PD-L1-negative population analysis set included the subset of participants in the China FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Only participants randomized in China cohort were analyzed. | months | MEDIAN |
| SECONDARY | OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months). | Participants included in bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb, PD-L1-Negative NSCLC, bTMB \<20 mut/Mb, bTMB non-evaluable population, tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb, and tTMB ≥8 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort. | months | MEDIAN |
| SECONDARY | OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets | From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global or China cohort DCO dates, as applicable (a maximum of approximately 44 months) for each cohort. | Participants included in FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% analysis sets are reported in this outcome measure. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months). | Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb, tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb, and tTMB ≥8 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort. | months | MEDIAN |
| SECONDARY | PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort. | Participants included in PD-L1-negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% analysis sets are reported in this outcome measure. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months). | Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb, tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb, and tTMB ≥8 mut/Mb analysis sets with measurable disease are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort. | percentage of participants | NUMBER |
| SECONDARY | ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort. | Participants included in PD-L1-negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% analysis sets with measurable disease are reported in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months). | Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, and bTMB ≥12 mut/Mb analysis sets are reported in this outcome measure. Only participants with objective response and randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort. | months | MEDIAN |
| SECONDARY | DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets | Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort. | Participants included in PD-L1-negative NSCLC and FAS analysis sets are reported in this outcome measure. Only participants with objective response were included in this analysis. | months | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group236
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set | Global: Durvalumab + Tremelimumab | 11.7 | 95% Confidence Interval 8.6 to 15.2 | months | |
| Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set | Global: SoC Chemotherapy | 9.1 | 95% Confidence Interval 7.8 to 12.6 | months | |
| OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set | China: Durvalumab + Tremelimumab | 15.0 | 95% Confidence Interval 10.5 to 27.4 | months | |
| OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set | China: SoC Chemotherapy | 11.7 | 95% Confidence Interval 8.6 to 20.5 | months | |
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Global: Durvalumab + Tremelimumab | bTMB ≥16 mut/Mb analysis set | 12.1 | 95% Confidence Interval 8.6 to 15.0 | months |
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Global: SoC Chemotherapy | bTMB ≥16 mut/Mb analysis set | 11.9 | 95% Confidence Interval 8.5 to 15.9 | months |
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Global: Durvalumab + Tremelimumab | bTMB ≥12 mut/Mb analysis set | 10.9 | 95% Confidence Interval 8.6 to 12.6 | months |
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Global: SoC Chemotherapy | bTMB ≥12 mut/Mb analysis set | 10.3 | 95% Confidence Interval 8.3 to 12.9 | months |
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Global: Durvalumab + Tremelimumab | PD-L1 negative analysis set | 11.1 | 95% Confidence Interval 8.1 to 14.7 | months |
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets | Global: SoC Chemotherapy | PD-L1 negative analysis set | 12.5 | 95% Confidence Interval 9.9 to 16.2 | months |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants: Durvalumab + Tremelimumab | 474 | |
| Overall Study | STARTED | All Participants: SoC Chemotherapy | 479 | |
| Overall Study | Randomized in Global Cohort | All Participants: Durvalumab + Tremelimumab | 410 | |
| Overall Study | Randomized in Global Cohort | All Participants: SoC Chemotherapy | 413 | |
| Overall Study | Received Treatment in Global Cohort | All Participants: Durvalumab + Tremelimumab | 410 | |
| Overall Study | Received Treatment in Global Cohort | All Participants: SoC Chemotherapy | 399 | |
| Overall Study | Randomized in China Cohort | All Participants: Durvalumab + Tremelimumab | 78 | |
| Overall Study | Randomized in China Cohort | All Participants: SoC Chemotherapy | 82 | |
| Overall Study | Received Treatment in China Cohort | All Participants: Durvalumab + Tremelimumab | 77 | |
| Overall Study | Received Treatment in China Cohort | All Participants: SoC Chemotherapy | 78 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,196
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 | Global: Durvalumab + Tremelimumab | 59 | 410 | 66 |
| other | Anaemia | Blood and lymphatic system disorders | Global: SoC Chemotherapy | 146 | 399 | 201 |
| other | Anaemia | Blood and lymphatic system disorders | China: Durvalumab + Tremelimumab | 25 | 77 | 35 |
| other | Anaemia | Blood and lymphatic system disorders | China: SoC Chemotherapy | 53 | 78 | 74 |
| other | Leukopenia | Blood and lymphatic system disorders | Global: Durvalumab + Tremelimumab | 2 | 410 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Global: SoC Chemotherapy | 38 | 399 | 55 |
| other | Leukopenia | Blood and lymphatic system disorders | China: Durvalumab + Tremelimumab | 1 | 77 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | China: SoC Chemotherapy | 13 | 78 | 21 |
| other | Neutropenia | Blood and lymphatic system disorders | Global: Durvalumab + Tremelimumab | 3 | 410 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Global: SoC Chemotherapy | 71 | 399 | 113 |
1 to 10 of 1,196Source ClinicalTrials.gov
See all 1,196 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Global: Durvalumab + Tremelimumab | 328 | 410 |
| Total, all-cause mortality | Global: SoC Chemotherapy | 329 | 413 |
| Total, all-cause mortality | China: Durvalumab + Tremelimumab | 50 | 78 |
| Total, all-cause mortality | China: SoC Chemotherapy | 62 | 82 |
| Total, other adverse events | Global: Durvalumab + Tremelimumab | 310 | 410 |
| Total, other adverse events | Global: SoC Chemotherapy | 349 | 399 |
| Total, other adverse events | China: Durvalumab + Tremelimumab | 73 | 77 |
| Total, other adverse events | China: SoC Chemotherapy | 77 | 78 |
| Total, serious adverse events | Global: Durvalumab + Tremelimumab | 193 | 410 |
| Total, serious adverse events | Global: SoC Chemotherapy | 112 | 399 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36806898 | DERIVED |
Source PubMed
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.
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