Trial · NCT03043872
Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
NCT03043872, Phase 3, Active not recruiting, AstraZeneca; results first posted 2021-03-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN). Trials, record NCT03043872. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03043872
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
- NCT number
- NCT03043872
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 987 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Small Cell Lung Carcinoma Extensive Disease
- Interventions
- Durvalumab, Tremelimumab, Carboplatin, Cisplatin, Etoposide
- First posted
- 2017-02-06
- Last updated
- 2026-07-16
- Other registries' IDs
- eudract:2016-001203-23
- Results first posted
- 2021-03-04
- Limitations and caveats
Analysis of the China cohort was performed to evaluate the consistency of efficacy and safety in Chinese patients with the global cohort in order to meet regulatory requirements and was not powered for a formal assessment of statistical significance.
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP | From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months). | OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An interim analysis of OS in the global cohort was pre-specified after approximately 318 OS events occurred each between the D + EP and EP groups (60% maturity), and between the D + T + EP and EP groups (60% maturity). At the global cohort interim analysis DCO (11 March 2019), comparison of OS in the D + EP versus (vs) EP groups had crossed the pre-specified boundary. Since these results were considered final in terms of formal statistical testing, they are presented here as a primary outcome measure. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the global cohort final analysis is presented separately in the subsequent primary outcome measure. |
| Primary | OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP | From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This primary outcome measure presents OS for the analysis of D + EP vs EP and D + T + EP vs EP at the time of the global cohort final analysis DCO (27 January 2020). Analysis of D + EP vs EP at the global cohort interim analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (global cohort final analysis) is presented as a secondary outcome measure. |
| Primary | OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP | From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months). | OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + EP vs EP in the China cohort was pre-specified at approximately 60% maturity (to ensure a similar maturity to the interim analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP at the China cohort first analysis DCO (06 January 2020), and is comparable in terms of maturity with the interim analysis of OS for D + EP vs EP in the Global cohort. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the China cohort second analysis is presented separately in the subsequent primary outcome measure. |
| Primary | OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP | From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months). | OS was defined as the time from date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An analysis of OS for D + T + EP vs EP in the China cohort was pre-specified at approximately 80% maturity (to ensure a similar maturity to the final analysis of the Global cohort). This primary outcome measure presents OS for analysis of D + EP vs EP and D + T + EP vs EP at the time of the China cohort second analysis DCO (02 November 2020), and is comparable in terms of maturity with the final analysis of OS for D + EP vs EP and D + T + EP vs EP in the Global cohort. Analysis of D + EP vs EP at the China cohort first analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (China cohort second analysis) is presented as a secondary outcome measure. |
| Secondary | OS in the Global Cohort; D + T + EP Compared With D + EP | From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP in the global cohort. The alternative treatment comparisons in the global cohort were performed as primary outcome measures. |
| Secondary | Progression-Free Survival (PFS) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 \[RECIST 1.1\] using Investigator assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (ie, PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) and an absolute increase of ≥5 millimeters (mm) for the sum from nadir. For evaluation of non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Median PFS was calculated using the Kaplan-Meier technique. |
| Secondary | Objective Response Rate (ORR) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR). CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size \[\<10 mm short axis\]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters). |
| Secondary | Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization. | The APF6 was defined as the percentage of patients who were alive and progression free at 6 months from randomization (ie, PFS rate at 6 months). PFS was calculated using the Kaplan-Meier technique. |
| Secondary | Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization. | The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PFS was calculated using the Kaplan-Meier technique. |
| Secondary | Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort | At 18 months post-randomization. Assessed at the global cohort final analysis DCO (27 January 2020). | OS18 was defined as the percentage of patients who were alive at 18 months after randomization per the Kaplan-Meier estimate of OS at 18 months. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP | From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months). | The global FAS included all patients randomized prior to the end of global recruitment. Interim analysis for OS in the global cohort was performed for comparison of the D + EP vs EP groups only. | months | MEDIAN |
| PRIMARY | OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP | From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. | months | MEDIAN |
| PRIMARY | OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP | From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months). | The China FAS included all randomized patients in the China cohort. China cohort first analysis for OS was performed for comparison of the D + EP vs EP groups only. | months | MEDIAN |
| PRIMARY | OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP | From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months). | The China FAS included all randomized patients in the China cohort. | months | MEDIAN |
| SECONDARY | OS in the Global Cohort; D + T + EP Compared With D + EP | From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. The denominator was a subset of the FAS population who had measurable disease at baseline. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization. | The global FAS included all patients randomized prior to the end of global recruitment. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization. | The global FAS included all patients randomized prior to the end of global recruitment. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort | At 18 months post-randomization. Assessed at the global cohort final analysis DCO (27 January 2020). | The global FAS included all patients randomized prior to the end of global recruitment. | percentage of patients | NUMBER |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group276
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP | Global Cohort: D + EP | 13.0 | 95% Confidence Interval 11.5 to 14.8 | months | |
| Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP | Global Cohort: EP | 10.3 | 95% Confidence Interval 9.3 to 11.2 | months | |
| OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP | Global Cohort: D + T + EP | 10.4 | 95% Confidence Interval 9.6 to 12.0 | months | |
| OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP | Global Cohort: D + EP | 12.9 | 95% Confidence Interval 11.3 to 14.7 | months | |
| OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP | Global Cohort: EP | 10.5 | 95% Confidence Interval 9.3 to 11.2 | months | |
| OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP | China Cohort: D + EP | 14.4 | 95% Confidence Interval 12.3 to NA | months | |
| OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP | China Cohort: EP | 10.9 | 95% Confidence Interval 8.9 to 14.0 | months | |
| OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP | China Cohort: D + T + EP | 16.1 | 95% Confidence Interval 11.3 to 18.6 | months | |
| OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP | China Cohort: D + EP | 14.4 | 95% Confidence Interval 12.3 to 17.0 | months | |
| OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP | China Cohort: EP | 10.9 | 95% Confidence Interval 8.9 to 14.0 | months |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Patients: D + T + EP | 329 | |
| Overall Study | STARTED | All Patients: D + EP | 328 | |
| Overall Study | STARTED | All Patients: EP | 330 | |
| Overall Study | Randomized and Included in Global Cohort Analysis | All Patients: D + T + EP | 268 | |
| Overall Study | Randomized and Included in Global Cohort Analysis | All Patients: D + EP | 268 | |
| Overall Study | Randomized and Included in Global Cohort Analysis | All Patients: EP | 269 | |
| Overall Study | Received Treatment in Global Cohort | All Patients: D + T + EP | 266 | |
| Overall Study | Received Treatment in Global Cohort | All Patients: D + EP | 265 | |
| Overall Study | Received Treatment in Global Cohort | All Patients: EP | 266 | |
| Overall Study | Randomized and Included in China Cohort Analysis | All Patients: D + T + EP | 65 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,860
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 | Diarrhoea | Gastrointestinal disorders | Global Cohort: D + T + EP | 40 | 266 | 54 |
| other | Diarrhoea | Gastrointestinal disorders | Global Cohort: D + EP | 27 | 265 | 37 |
| other | Diarrhoea | Gastrointestinal disorders | Global Cohort: EP | 29 | 266 | 34 |
| other | Diarrhoea | Gastrointestinal disorders | China Cohort: D + T + EP | 16 | 65 | 26 |
| other | Diarrhoea | Gastrointestinal disorders | China Cohort: D + EP | 5 | 61 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | China Cohort: EP | 5 | 62 | 5 |
| other | Asthenia | General disorders | Global Cohort: D + T + EP | 37 | 266 | 47 |
| other | Asthenia | General disorders | Global Cohort: D + EP | 42 | 265 | 50 |
| other | Asthenia | General disorders | Global Cohort: EP | 39 | 266 | 50 |
| other | Asthenia | General disorders | China Cohort: D + T + EP | 10 | 65 | 11 |
1 to 10 of 1,860Source ClinicalTrials.gov
See all 1,860 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Global Cohort: D + T + EP | 225 | 266 |
| Total, all-cause mortality | Global Cohort: D + EP | 218 | 265 |
| Total, all-cause mortality | Global Cohort: EP | 247 | 266 |
| Total, all-cause mortality | China Cohort: D + T + EP | 50 | 65 |
| Total, all-cause mortality | China Cohort: D + EP | 51 | 61 |
| Total, all-cause mortality | China Cohort: EP | 55 | 62 |
| Total, other adverse events | Global Cohort: D + T + EP | 249 | 266 |
| Total, other adverse events | Global Cohort: D + EP | 247 | 265 |
| Total, other adverse events | Global Cohort: EP | 248 | 266 |
| Total, other adverse events | China Cohort: D + T + EP | 65 | 65 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
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.
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