Trial · NCT04005716
Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
NCT04005716, Phase 3, Completed, BeiGene; results first posted 2025-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer. Trials, record NCT04005716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04005716
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT04005716
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 457 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Small Cell Lung Cancer
- Interventions
- Tislelizumab, Cisplatin, Carboplatin, Etoposide, Placebo
- First posted
- 2019-07-02
- Last updated
- 2025-02-28
- Results first posted
- 2025-02-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. |
| Secondary | Progression Free Survival (PFS) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Kaplan-Meier methodology was used to estimate the median PFS. Progressive Disease (PD): At least a 20% increase in the size of target lesions, with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or any new lesions. |
| Secondary | Overall Response Rate (ORR) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Orr is defined as the percentage of participants who had partial response or complete response as determined by the investigator per RECIST v1.1 in all randomized patients with measurable disease at baseline. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions. |
| Secondary | Disease Control Rate (DCR) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease per RECIST v1.1. Stable Disease: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for progressive disease, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. |
| Secondary | Clinical Benefit Rate (CBR) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or durable stable disease (stable disease for at least 24 weeks) per RECIST v1.1. |
| Secondary | Duration of Response (DOR) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the investigator per RECIST v1.1, or death from any cause, whichever comes first. Median DOR was estimated using Kaplan-Meier methodology. |
| Secondary | Number of Participants With Adverse Events | From the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B. | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. |
| Secondary | Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status and Physical Function Score. | Baseline to Cycles 4 and 6 ( Each cycle was 21 days) | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. |
| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores | Baseline to Cycles 4 and 6 ( Each cycle was 21 days) | Change from baseline in EORTC QLQ-CL13 scores for coughing, dysphagia, and chest pain. The EORTC QLQ-LC13 is a questionnaire that measures lung cancer-specific disease and treatment symptoms. It includes questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. A lower score indicates an improvement in symptoms. |
| Secondary | Time to Deterioration (TTD) | From randomization to the primary completion data cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Time to deterioration is defined as the time from randomization to the first confirmed worsening score or death. Clinically meaningful deterioration is defined as a ≥10-point decrease from baseline in QLQ-C30 physical functioning and a ≥10-point increase in QLQ-LC13 coughing and chest pain scores. If a participant did not have an event (death or deterioration), they were censored at their last clinic visit at which corresponding score was measured. Median TTD was estimated using Kaplan-Meier methodology. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Intent to treat analysis set | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Intent to treat analysis set | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Intent to treat analysis set | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Intent to treat analysis set | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Intent to treat analysis set | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | Intent to treat analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis, and percentages were based on the number of responders | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | From the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B. | The Safety Analysis Set includes all participants randomized and received any dose of any study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status and Physical Function Score. | Baseline to Cycles 4 and 6 ( Each cycle was 21 days) | The HRQoL analysis set included all randomized participants who received any dose of study drug and completed at least one HRQoL assessment. Only participants with data at both baseline and corresponding post-baseline visit are included in the analysis at each time point. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores | Baseline to Cycles 4 and 6 ( Each cycle was 21 days) | HRQoL analysis set. Only participants with data at both baseline and corresponding post-baseline visit are included in the analysis at each time point. | score on a scale | MEAN |
| SECONDARY | Time to Deterioration (TTD) | From randomization to the primary completion data cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B. | HRQoL analysis set | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Arm A: Tislelizumab + Chemotherapy | 15.5 | 95% Confidence Interval 13.5 to 17.1 | Months | |
| Overall Survival (OS) | Arm B: Placebo + Chemotherapy | 13.5 | 95% Confidence Interval 12.1 to 14.9 | Months | |
| Progression Free Survival (PFS) | Arm A: Tislelizumab + Chemotherapy | 4.7 | 95% Confidence Interval 4.3 to 5.5 | Months | |
| Progression Free Survival (PFS) | Arm B: Placebo + Chemotherapy | 4.3 | 95% Confidence Interval 4.2 to 4.4 | Months | |
| Overall Response Rate (ORR) | Arm A: Tislelizumab + Chemotherapy | 68.3 | 95% Confidence Interval 61.8 to 74.3 | percentage of participants | |
| Overall Response Rate (ORR) | Arm B: Placebo + Chemotherapy | 61.7 | 95% Confidence Interval 55.1 to 68.0 | percentage of participants | |
| Disease Control Rate (DCR) | Arm A: Tislelizumab + Chemotherapy | 88.5 | 95% Confidence Interval 83.7 to 92.4 | percentage of participants | |
| Disease Control Rate (DCR) | Arm B: Placebo + Chemotherapy | 88.3 | 95% Confidence Interval 83.4 to 92.1 | percentage of participants | |
| Clinical Benefit Rate (CBR) | Arm A: Tislelizumab + Chemotherapy | 69.2 | 95% Confidence Interval 62.7 to 75.1 | percentage of participants | |
| Clinical Benefit Rate (CBR) | Arm B: Placebo + Chemotherapy | 65.2 | 95% Confidence Interval 58.7 to 71.4 | percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Tislelizumab + Chemotherapy | 227 | |
| Overall Study | STARTED | Arm B: Placebo + Chemotherapy | 230 | |
| Overall Study | Treated | Arm A: Tislelizumab + Chemotherapy | 227 | |
| Overall Study | Treated | Arm B: Placebo + Chemotherapy | 229 | |
| Overall Study | COMPLETED | Arm A: Tislelizumab + Chemotherapy | 49 | |
| Overall Study | COMPLETED | Arm B: Placebo + Chemotherapy | 26 | |
| Overall Study | NOT COMPLETED | Arm A: Tislelizumab + Chemotherapy | 178 | |
| Overall Study | NOT COMPLETED | Arm B: Placebo + Chemotherapy | 204 |
Source ClinicalTrials.gov
Adverse events360
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 | Arm A: Tislelizumab + Chemotherapy | 192 | 227 | 356 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Placebo + Chemotherapy | 191 | 229 | 329 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Tislelizumab + Chemotherapy | 74 | 227 | 205 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: Placebo + Chemotherapy | 55 | 229 | 173 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Tislelizumab + Chemotherapy | 149 | 227 | 445 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: Placebo + Chemotherapy | 157 | 229 | 492 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: Tislelizumab + Chemotherapy | 108 | 227 | 247 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B: Placebo + Chemotherapy | 114 | 229 | 248 |
| other | Sinus tachycardia | Cardiac disorders | Arm A: Tislelizumab + Chemotherapy | 10 | 227 | 13 |
| other | Sinus tachycardia | Cardiac disorders | Arm B: Placebo + Chemotherapy | 0 | 229 | 0 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Tislelizumab + Chemotherapy | 175 | 227 |
| Total, all-cause mortality | Arm B: Placebo + Chemotherapy | 196 | 230 |
| Total, other adverse events | Arm A: Tislelizumab + Chemotherapy | 226 | 227 |
| Total, other adverse events | Arm B: Placebo + Chemotherapy | 228 | 229 |
| Total, serious adverse events | Arm A: Tislelizumab + Chemotherapy | 94 | 227 |
| Total, serious adverse events | Arm B: Placebo + Chemotherapy | 70 | 229 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Tislelizumab + Chemotherapy vs Arm B: Placebo + Chemotherapy: deaths from any cause | Trial comparisons |
| Arm A: Tislelizumab + Chemotherapy vs Arm B: Placebo + Chemotherapy: 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.
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/NCT04005716
GET https://conductscience.org/api/trials/v1/NCT04005716/results?page=2