Trial · NCT05091567
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
NCT05091567, Phase 3, Active not recruiting, Hoffmann-La Roche; results first posted 2025-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer. Trials, record NCT05091567. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05091567
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
- NCT number
- NCT05091567
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 660 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Small-Cell Lung Cancer
- Interventions
- Atezolizumab, Lurbinectedin, Carboplatin, Etoposide
- First posted
- 2021-10-25
- Last updated
- 2026-09-09
- Results first posted
- 2025-12-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS) | Up to 26 months | PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetres (mm). |
| Primary | Randomized Phase: Overall Survival (OS) | Up to 26 months | OS was defined as the time from randomization to the date of death from any cause. |
| Secondary | Randomized Phase: Investigator-assessed PFS | Up to 26 months | PFS was defined as the time from randomization to the date of first documented PD as assessed by investigator according to RECIST v1.1 or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF | Up to 26 months | ORR was defined as the percentage of participants with an objective tumor response of complete response (CR) or partial response (PR) as determined by the IRF using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off. |
| Secondary | Randomized Phase: Confirmed ORR as Determined by the Investigator | Up to 26 months | ORR was defined as the percentage of participants with an objective tumor response of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. |
| Secondary | Randomized Phase: Duration of Response (DOR) as Determined by the IRF | Up to 26 months | DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR= time from first occurrence of a documented OR until the time of documented PD as determined by IRF assessment using RECIST v1.1 or death from any cause, whichever occurs first. CR=disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR= at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Randomized Phase: DOR as Determined by the Investigator | Up to 26 months | DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR= time from first occurrence of a documented OR until the time of documented PD as determined by investigator using RECIST v1.1 or death from any cause, whichever occurs first. CR=disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR= at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Randomized Phase: Percentage of Participants With PFS as Determined by the IRF at 6 Months and 12 Months | Months 6 and 12 | PFS rate at 6 months and 12 months was defined as the percentage of participants who had not experienced PD as determined by the IRF according to RECIST v1.1 or death from any cause at 6 months and 12 months after randomization. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off. |
| Secondary | Randomized Phase: Percentage of Participants With PFS Determined by Investigator at 6 Months and 12 Months | Months 6 and 12 | PFS rate at 6 months and 12 months was defined as the percentage of participants who had not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 months and 12 months after randomization. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off. |
| Secondary | Randomized Phase: Percentage of Participants With OS at 12 Months and 24 Months | Months 12 and 24 | OS rate at 12 months and 24 months was defined as the percentage of participants who had not experienced death from any cause at 12 months and 24 months after randomization. Percentages have been rounded off. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS) | Up to 26 months | FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. | months | MEDIAN |
| PRIMARY | Randomized Phase: Overall Survival (OS) | Up to 26 months | FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Randomized Phase: Investigator-assessed PFS | Up to 26 months | FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF | Up to 26 months | FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with measurable disease at baseline, as assessed by IRF. | percentage of participants | NUMBER |
| SECONDARY | Randomized Phase: Confirmed ORR as Determined by the Investigator | Up to 26 months | FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with measurable disease at baseline, as assessed by investigator. | percentage of participants | NUMBER |
| SECONDARY | Randomized Phase: Duration of Response (DOR) as Determined by the IRF | Up to 26 months | FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with response, per IRF. | months | MEDIAN |
| SECONDARY | Randomized Phase: DOR as Determined by the Investigator | Up to 26 months | FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with response, per investigator. | months | MEDIAN |
| SECONDARY | Randomized Phase: Percentage of Participants With PFS as Determined by the IRF at 6 Months and 12 Months | Months 6 and 12 | FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | Randomized Phase: Percentage of Participants With PFS Determined by Investigator at 6 Months and 12 Months | Months 6 and 12 | FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | Randomized Phase: Percentage of Participants With OS at 12 Months and 24 Months | Months 12 and 24 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS) | Atezolizumab | 2.14 | 95% Confidence Interval 1.64 | months | |
| Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS) | Atezolizumab+ Lurbinectedin | 5.36 | 95% Confidence Interval 4.24 | months | |
| Randomized Phase: Overall Survival (OS) | Atezolizumab | 10.64 | 95% Confidence Interval 9.49 | months | |
| Randomized Phase: Overall Survival (OS) | Atezolizumab+ Lurbinectedin | 13.24 | 95% Confidence Interval 11.89 | months | |
| Randomized Phase: Investigator-assessed PFS | Atezolizumab | 2.73 | 95% Confidence Interval 2.53 | months | |
| Randomized Phase: Investigator-assessed PFS | Atezolizumab+ Lurbinectedin | 5.36 | 95% Confidence Interval 4.30 | months | |
| Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF | Atezolizumab | 10.4 | 95% Confidence Interval 6.40 | percentage of participants | |
| Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF | Atezolizumab+ Lurbinectedin | 19.4 | 95% Confidence Interval 13.85 | percentage of participants | |
| Randomized Phase: Confirmed ORR as Determined by the Investigator | Atezolizumab | 13.2 | 95% Confidence Interval 8.86 | percentage of participants | |
| Randomized Phase: Confirmed ORR as Determined by the Investigator | Atezolizumab+ Lurbinectedin | 17.1 | 95% Confidence Interval 12.19 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrollment Phase | STARTED | Atezolizumab + Carboplatin + Etoposide | 660 | |
| Enrollment Phase | STARTED | Atezolizumab | 0 | |
| Enrollment Phase | STARTED | Atezolizumab+ Lurbinectedin | 0 | |
| Enrollment Phase | Enrolled Safety Analysis Set (SAS) | Atezolizumab + Carboplatin + Etoposide | 653 | |
| Enrollment Phase | Enrolled Safety Analysis Set (SAS) | Atezolizumab | 0 | |
| Enrollment Phase | Enrolled Safety Analysis Set (SAS) | Atezolizumab+ Lurbinectedin | 0 | |
| Enrollment Phase | COMPLETED | Atezolizumab + Carboplatin + Etoposide | 571 | |
| Enrollment Phase | COMPLETED | Atezolizumab | 0 | |
| Enrollment Phase | COMPLETED | Atezolizumab+ Lurbinectedin | 0 | |
| Enrollment Phase | NOT COMPLETED | Atezolizumab + Carboplatin + Etoposide | 89 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events588
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 | Alopecia | Skin and subcutaneous tissue disorders | Atezolizumab + Carboplatin + Etoposide | 108 | 653 | 110 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Atezolizumab | 2 | 240 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Atezolizumab+ Lurbinectedin | 1 | 242 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Atezolizumab + Carboplatin + Etoposide | 32 | 653 | 34 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Atezolizumab | 17 | 240 | 20 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Atezolizumab+ Lurbinectedin | 18 | 242 | 20 |
| other | Hypothyroidism | Endocrine disorders | Atezolizumab + Carboplatin + Etoposide | 15 | 653 | 15 |
| other | Hypothyroidism | Endocrine disorders | Atezolizumab | 17 | 240 | 22 |
| other | Hypothyroidism | Endocrine disorders | Atezolizumab+ Lurbinectedin | 17 | 242 | 18 |
| other | Asthenia | General disorders | Atezolizumab + Carboplatin + Etoposide | 68 | 653 | 81 |
1 to 10 of 588Source ClinicalTrials.gov
See all 588 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atezolizumab + Carboplatin + Etoposide | 54 | 660 |
| Total, all-cause mortality | Atezolizumab | 135 | 241 |
| Total, all-cause mortality | Atezolizumab+ Lurbinectedin | 113 | 242 |
| Total, other adverse events | Atezolizumab + Carboplatin + Etoposide | 526 | 653 |
| Total, other adverse events | Atezolizumab | 127 | 240 |
| Total, other adverse events | Atezolizumab+ Lurbinectedin | 213 | 242 |
| Total, serious adverse events | Atezolizumab + Carboplatin + Etoposide | 181 | 653 |
| Total, serious adverse events | Atezolizumab | 41 | 240 |
| Total, serious adverse events | Atezolizumab+ Lurbinectedin | 75 | 242 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40473449 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atezolizumab vs Atezolizumab+ Lurbinectedin: Randomized Phase: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab |
Source 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.
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/NCT05091567
GET https://conductscience.org/api/trials/v1/NCT05091567/results?page=2