Trial · NCT04256421
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
NCT04256421, Phase 3, Completed, Hoffmann-La Roche; results first posted 2025-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer. Trials, record NCT04256421. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04256421
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT04256421
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 490 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Small Cell Lung Cancer
- Interventions
- Tiragolumab, Atezolizumab, Carboplatin, Etoposide, Placebo
- First posted
- 2020-02-05
- Last updated
- 2026-04-03
- Other registries' IDs
- eudract:2019-003301-97
- Results first posted
- 2025-10-22
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) | From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months) | PFS was defined as the time from randomization to the first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). |
| Primary | Overall Survival (OS) in the PAS | From randomization to death from any cause (up to approximately 24 months) | OS was defined as the time from randomization to death from any cause. |
| Secondary | PFS in the FAS | From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months) | PFS was defined as the time from randomization to the first documented PD as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. |
| Secondary | OS in the FAS | From randomization to death from any cause (up to approximately 24 months) | OS was defined as the time from randomization to death from any cause. |
| Secondary | Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS | From randomization up to approximately 24 months | ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. |
| Secondary | Investigator-assessed Confirmed ORR in the FAS | From randomization up to approximately 24 months | ORR was defined as the percentage of participants with CR or PR as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. |
| Secondary | Investigator-assessed Duration of Response (DOR) in the PAS | From the first occurrence of a documented confirmed objective response (OR) to PD or death from any cause, whichever occurred first (up to approximately 24 months) | DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. |
| Secondary | Investigator-assessed DOR in the FAS | From the first occurrence of a documented confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 24 months) | DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. |
| Secondary | Investigator-assessed PFS Rates at 6 Months and 12 Months in the PAS | Month 6, Month 12 | PFS rate at 6 months and 12 months was defined as the percentage of participants who were event-free at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the Kaplan-Meier (K-M) method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk). |
| Secondary | Investigator-assessed PFS Rates at 6 Months and 12 Months in the FAS | Month 6, Month 12 | PFS rate at 6 months and 12 months was defined as the percentage of participants who were event-free at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the K-M method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk). |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS) | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months) | Primary analysis set (PAS): All randomized participants without presence or history of brain metastases at baseline. | months | MEDIAN |
| PRIMARY | Overall Survival (OS) in the PAS | From randomization to death from any cause (up to approximately 24 months) | PAS: All randomized participants without presence or history of brain metastases at baseline. | months | MEDIAN |
| SECONDARY | PFS in the FAS | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months) | FAS: All randomized participants, whether or not the participant received the assigned treatment. | months | MEDIAN |
| SECONDARY | OS in the FAS | From randomization to death from any cause (up to approximately 24 months) | FAS: All randomized participants, whether or not the participant received the assigned treatment. | months | MEDIAN |
| SECONDARY | Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS | From randomization up to approximately 24 months | PAS: All randomized participants without presence or history of brain metastases at baseline. | percentage of participants | NUMBER |
| SECONDARY | Investigator-Assessed Confirmed ORR in the FAS | From randomization up to approximately 24 months | FAS: All randomized participants, whether or not the participant received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Investigator-Assessed Duration of Response (DOR) in the PAS | From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) | PAS: All randomized participants without presence or history of brain metastases at baseline. DOR was analyzed in confirmed responders by investigator. | months | MEDIAN |
| SECONDARY | Investigator-Assessed DOR in the FAS | From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) | FAS: All randomized participants, whether or not the participant received the assigned treatment. DOR was analyzed in confirmed responders by investigator. | months | MEDIAN |
| SECONDARY | Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS | Month 6, Month 12 | PAS: All randomized participants without presence or history of brain metastases at baseline. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | percentage of participants | NUMBER |
| SECONDARY | Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS | Month 6, Month 12 | FAS: All randomized participants, whether or not the participant received the assigned treatment. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | percentage of participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS) | Placebo + Atezolizumab | 5.55 | 95% Confidence Interval 5.36 to 5.85 | months | |
| Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS) | Tiragolumab + Atezolizumab | 5.36 | 95% Confidence Interval 4.67 to 5.52 | months | |
| Overall Survival (OS) in the PAS | Placebo + Atezolizumab | 13.14 | 95% Confidence Interval 12.16 to 15.11 | months | |
| Overall Survival (OS) in the PAS | Tiragolumab + Atezolizumab | 13.11 | 95% Confidence Interval 10.84 to 14.39 | months | |
| PFS in the FAS | Placebo + Atezolizumab | 5.42 | 95% Confidence Interval 4.47 to 5.65 | months | |
| PFS in the FAS | Tiragolumab + Atezolizumab | 5.06 | 95% Confidence Interval 4.40 to 5.42 | months | |
| OS in the FAS | Placebo + Atezolizumab | 12.91 | 95% Confidence Interval 11.99 to 14.52 | months | |
| OS in the FAS | Tiragolumab + Atezolizumab | 12.75 | 95% Confidence Interval 10.84 to 14.29 | months | |
| Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS | Placebo + Atezolizumab | 66.7 | 95% Confidence Interval 59.64 to 73.05 | percentage of participants | |
| Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS | Tiragolumab + Atezolizumab | 73.5 | 95% Confidence Interval 66.61 to 79.39 | percentage of participants |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Atezolizumab | 247 | |
| Overall Study | STARTED | Tiragolumab + Atezolizumab | 243 | |
| Overall Study | Safety-evaluable Set | Placebo + Atezolizumab | 246 | |
| Overall Study | Safety-evaluable Set | Tiragolumab + Atezolizumab | 239 | |
| Overall Study | COMPLETED | Placebo + Atezolizumab | 0 | |
| Overall Study | COMPLETED | Tiragolumab + Atezolizumab | 0 | |
| Overall Study | NOT COMPLETED | Placebo + Atezolizumab | 247 | |
| Overall Study | NOT COMPLETED | Tiragolumab + Atezolizumab | 243 |
Source ClinicalTrials.gov
Adverse events372
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 | Placebo + Atezolizumab | 97 | 246 | 127 |
| other | Anaemia | Blood and lymphatic system disorders | Tiragolumab + Atezolizumab | 86 | 239 | 106 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Atezolizumab | 13 | 246 | 21 |
| other | Leukopenia | Blood and lymphatic system disorders | Tiragolumab + Atezolizumab | 13 | 239 | 17 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Atezolizumab | 72 | 246 | 136 |
| other | Neutropenia | Blood and lymphatic system disorders | Tiragolumab + Atezolizumab | 63 | 239 | 91 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Atezolizumab | 31 | 246 | 53 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tiragolumab + Atezolizumab | 29 | 239 | 46 |
| other | Hyperthyroidism | Endocrine disorders | Placebo + Atezolizumab | 17 | 246 | 19 |
| other | Hyperthyroidism | Endocrine disorders | Tiragolumab + Atezolizumab | 16 | 239 | 16 |
1 to 10 of 372Source ClinicalTrials.gov
See all 372 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Atezolizumab | 171 | 247 |
| Total, all-cause mortality | Tiragolumab + Atezolizumab | 180 | 243 |
| Total, other adverse events | Placebo + Atezolizumab | 233 | 246 |
| Total, other adverse events | Tiragolumab + Atezolizumab | 228 | 239 |
| Total, serious adverse events | Placebo + Atezolizumab | 104 | 246 |
| Total, serious adverse events | Tiragolumab + Atezolizumab | 108 | 239 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37976444 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + Atezolizumab vs Tiragolumab + Atezolizumab: deaths from any cause | Trial comparisons |
| Placebo + Atezolizumab vs Tiragolumab + Atezolizumab: serious adverse events | Trial comparisons |
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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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/NCT04256421
GET https://conductscience.org/api/trials/v1/NCT04256421/registered?page=2