Trial · NCT03594747
A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
NCT03594747, Phase 3, Completed, BeiGene; results first posted 2023-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer. Trials, record NCT03594747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03594747
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
- NCT number
- NCT03594747
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 360 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Tislelizumab, Paclitaxel, Nab-paclitaxel, Carboplatin
- First posted
- 2018-07-20
- Last updated
- 2024-10-26
- Results first posted
- 2023-10-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 | Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months) | PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first |
| Primary | PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020 | Through primary analysis data cut-off date of 30SEP2020 (up to approximately 2 years and 2 months) | PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first |
| Secondary | Overall Survival (OS) | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | OS is defined as the time from randomization until the date of death due to any cause |
| Secondary | Objective Response Rate (ORR) by IRC Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the IRC using RECIST v1.1. |
| Secondary | ORR by Investigator Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the investigator using RECIST v1.1. |
| Secondary | Duration of Response (DOR) by IRC Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the IRC using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders. |
| Secondary | DOR by Investigator Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the investigator using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders. |
| Secondary | PFS by Investigator Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | PFS is defined as the time from randomization until first documentation of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first |
| Secondary | PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first, based on PD-L1 expression in tumor cells |
| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) | Baseline to Cycle 5; each cycle is 21 days | Least squares mean change from baseline in EORTC QLQ-CL13 scores for chest pain, coughing, and dyspnea between tislelizumab arms and paclitaxel + carboplatin arm. 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 | Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months) | ITT analysis set included all participants who were randomized | Months | MEDIAN |
| PRIMARY | PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020 | Through primary analysis data cut-off date of 30SEP2020 (up to approximately 2 years and 2 months) | ITT analysis set included all participants who were randomized | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | ITT analysis set included all participants who were randomized | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) by IRC Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | ITT analysis set included all participants who were randomized | Percentage of participants | NUMBER |
| SECONDARY | ORR by Investigator Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | ITT analysis set included all participants who were randomized | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) by IRC Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | ITT analysis set included all participants who were randomized | Months | MEDIAN |
| SECONDARY | DOR by Investigator Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | ITT analysis set included all participants who were randomized | Months | MEDIAN |
| SECONDARY | PFS by Investigator Assessment | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | ITT analysis set included all participants who were randomized | Months | MEDIAN |
| SECONDARY | PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression | Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months) | ITT analysis set included all participants who were randomized; participants evaluable for PD-L1 expression were included | Months | MEDIAN |
| SECONDARY | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) | Baseline to Cycle 5; each cycle is 21 days | Health-Related Quality of Life (HRQoL) analysis set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ HRQoL assessment post baseline | Score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 | Tislelizumab + Paclitaxel + Carboplatin | 7.6 | 95% Confidence Interval 5.95 to 9.79 | Months | |
| Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 | Tislelizumab + Nab-paclitaxel + Carboplatin | 7.6 | 95% Confidence Interval 5.75 to 11.01 | Months | |
| Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 | Paclitaxel + Carboplatin | 5.5 | 95% Confidence Interval 4.21 to 5.65 | Months | |
| PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020 | Tislelizumab + Paclitaxel + Carboplatin | 7.7 | 95% Confidence Interval 6.74 to 10.41 | Months | |
| PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020 | Tislelizumab + Nab-paclitaxel + Carboplatin | 9.6 | 95% Confidence Interval 7.39 to 10.78 | Months | |
| PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020 | Paclitaxel + Carboplatin | 5.5 | 95% Confidence Interval 4.21 to 5.59 | Months | |
| Overall Survival (OS) | Tislelizumab + Paclitaxel + Carboplatin | 26.1 | 95% Confidence Interval 18.99 to 33.81 | Months | |
| Overall Survival (OS) | Tislelizumab + Nab-paclitaxel + Carboplatin | 23.3 | 95% Confidence Interval 18.76 to 26.38 | Months | |
| Overall Survival (OS) | Paclitaxel + Carboplatin | 19.4 | 95% Confidence Interval 15.97 to 23.43 | Months | |
| Objective Response Rate (ORR) by IRC Assessment | Tislelizumab + Paclitaxel + Carboplatin | 74.2 | 95% Confidence Interval 65.4 to 81.7 | Percentage of participants |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tislelizumab + Paclitaxel + Carboplatin | 120 | |
| Overall Study | STARTED | Tislelizumab + Nab-paclitaxel + Carboplatin | 119 | |
| Overall Study | STARTED | Paclitaxel + Carboplatin | 121 | |
| Overall Study | Randomized But Not Treated | Tislelizumab + Paclitaxel + Carboplatin | 0 | |
| Overall Study | Randomized But Not Treated | Tislelizumab + Nab-paclitaxel + Carboplatin | 1 | |
| Overall Study | Randomized But Not Treated | Paclitaxel + Carboplatin | 4 | |
| Overall Study | COMPLETED | Tislelizumab + Paclitaxel + Carboplatin | 0 | |
| Overall Study | COMPLETED | Tislelizumab + Nab-paclitaxel + Carboplatin | 0 | |
| Overall Study | COMPLETED | Paclitaxel + Carboplatin | 0 | |
| Overall Study | NOT COMPLETED | Tislelizumab + Paclitaxel + Carboplatin | 120 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events663
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 | Tislelizumab + Paclitaxel + Carboplatin | 107 | 120 | 277 |
| other | Anaemia | Blood and lymphatic system disorders | Tislelizumab + Nab-Paclitaxel + Carboplatin | 111 | 118 | 297 |
| other | Anaemia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 94 | 117 | 198 |
| other | Leukocytosis | Blood and lymphatic system disorders | Tislelizumab + Paclitaxel + Carboplatin | 3 | 120 | 4 |
| other | Leukocytosis | Blood and lymphatic system disorders | Tislelizumab + Nab-Paclitaxel + Carboplatin | 4 | 118 | 5 |
| other | Leukocytosis | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 7 | 117 | 11 |
| other | Leukopenia | Blood and lymphatic system disorders | Tislelizumab + Paclitaxel + Carboplatin | 58 | 120 | 234 |
| other | Leukopenia | Blood and lymphatic system disorders | Tislelizumab + Nab-Paclitaxel + Carboplatin | 66 | 118 | 291 |
| other | Leukopenia | Blood and lymphatic system disorders | Paclitaxel + Carboplatin | 57 | 117 | 187 |
| other | Neutropenia | Blood and lymphatic system disorders | Tislelizumab + Paclitaxel + Carboplatin | 53 | 120 | 191 |
1 to 10 of 663Source ClinicalTrials.gov
See all 663 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tislelizumab + Paclitaxel + Carboplatin | 78 | 120 |
| Total, all-cause mortality | Tislelizumab + Nab-Paclitaxel + Carboplatin | 86 | 119 |
| Total, all-cause mortality | Paclitaxel + Carboplatin | 87 | 121 |
| Total, other adverse events | Tislelizumab + Paclitaxel + Carboplatin | 119 | 120 |
| Total, other adverse events | Tislelizumab + Nab-Paclitaxel + Carboplatin | 117 | 118 |
| Total, other adverse events | Paclitaxel + Carboplatin | 116 | 117 |
| Total, serious adverse events | Tislelizumab + Paclitaxel + Carboplatin | 56 | 120 |
| Total, serious adverse events | Tislelizumab + Nab-Paclitaxel + Carboplatin | 55 | 118 |
| Total, serious adverse events | Paclitaxel + Carboplatin | 29 | 117 |
Source ClinicalTrials.gov
Papers3
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.
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/NCT03594747
GET https://conductscience.org/api/trials/v1/NCT03594747/results?page=2