NCT03594747 is a Phase 3 clinical trial of Tislelizumab in Non-Small Cell Lung Cancer, sponsored by BeiGene.

Who is sponsoring NCT03594747?

NCT03594747 is sponsored by BeiGene.

What drugs are being tested in NCT03594747?

Interventions in NCT03594747: Tislelizumab, Paclitaxel, Nab-paclitaxel, Carboplatin.

What condition does NCT03594747 study?

NCT03594747 studies Non-Small Cell Lung Cancer.

Is NCT03594747 still recruiting?

NCT03594747 is currently completed. Last updated 26 October 2024.

Are results published for NCT03594747?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-26 · How we verify

NCT03594747

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer

Completed Phase 3 Results posted Last updated 26 October 2024

What this trial tests

Phase 3 trial testing Tislelizumab in Non-Small Cell Lung Cancer in 360 participants. Completed in 28 April 2023.

Timeline

30 July 2018

Primary endpoint
30 September 2020

28 April 2023

Quick facts

Lead sponsor	BeiGene
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	360
Start date	30 July 2018
Primary completion	30 September 2020
Estimated completion	28 April 2023
Sites	43 locations across China

Drugs / interventions tested

Tislelizumab (TISLELIZUMAB) — full drug profile →
Paclitaxel — full drug profile →
Nab-paclitaxel (nab-paclitaxel) — full drug profile →
Carboplatin (Carboplatin) — full drug profile →

Conditions studied

Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

BeiGene — full company profile →

Who can join

Adults 18 to 75, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 Primary · 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

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	7.6	5.95 – 9.79
Tislelizumab + Nab-paclitaxel + Carboplatin	7.6	5.75 – 11.01
Paclitaxel + Carboplatin	5.5	4.21 – 5.65

PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020 Primary · 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

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	7.7	6.74 – 10.41
Tislelizumab + Nab-paclitaxel + Carboplatin	9.6	7.39 – 10.78
Paclitaxel + Carboplatin	5.5	4.21 – 5.59

Overall Survival (OS) Secondary · 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

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	26.1	18.99 – 33.81
Tislelizumab + Nab-paclitaxel + Carboplatin	23.3	18.76 – 26.38
Paclitaxel + Carboplatin	19.4	15.97 – 23.43

Objective Response Rate (ORR) by IRC Assessment Secondary · 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.

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	74.2	65.4 – 81.7
Tislelizumab + Nab-paclitaxel + Carboplatin	73.9	65.1 – 81.6
Paclitaxel + Carboplatin	47.9	38.8 – 57.2

ORR by Investigator Assessment Secondary · 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.

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	70.0	61.0 – 78.0
Tislelizumab + Nab-paclitaxel + Carboplatin	78.2	69.6 – 85.2
Paclitaxel + Carboplatin	49.6	40.4 – 58.8

Duration of Response (DOR) by IRC Assessment Secondary · 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.

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	8.4	5.03 – 18.69
Tislelizumab + Nab-paclitaxel + Carboplatin	8.6	7.13 – 12.48
Paclitaxel + Carboplatin	4.3	2.86 – 5.42

DOR by Investigator Assessment Secondary · 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.

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	10.6	7.03 – 16.23
Tislelizumab + Nab-paclitaxel + Carboplatin	8.8	8.05 – 11.93
Paclitaxel + Carboplatin	4.8	2.86 – 6.11

PFS by Investigator Assessment Secondary · 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

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	9.6	7.62 – 11.76
Tislelizumab + Nab-paclitaxel + Carboplatin	9.8	8.57 – 11.86
Paclitaxel + Carboplatin	5.5	4.17 – 5.65

PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression Secondary · 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

PD-L Expression (<1%)

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	7.6	5.5 – 14.5
Tislelizumab + Nab-paclitaxel + Carboplatin	7.6	5.4 – 9.9
Paclitaxel + Carboplatin	5.5	4.2 – 7.0

PD-L Expression (1% to 49%)

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	9.9	5.5 – 22.7
Tislelizumab + Nab-paclitaxel + Carboplatin	9.8	7.6 – 12.0
Paclitaxel + Carboplatin	5.0	2.8 – 6.5

PD-L Expression (≥ 50%)

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	7.7	5.9 – 9.8
Tislelizumab + Nab-paclitaxel + Carboplatin	9.7	5.6 – 30.9
Paclitaxel + Carboplatin	5.5	4.1 – 5.6

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Secondary · 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.

Chest pain

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	0.4	-5.0 – 5.9
Tislelizumab + Nab-paclitaxel + Carboplatin	-0.4	-5.9 – 5.1

Coughing

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	-7.0	-14.3 – 0.2
Tislelizumab + Nab-paclitaxel + Carboplatin	-0.4	-7.7 – 6.8

Dyspnea

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	-2.7	-6.9 – 1.6
Tislelizumab + Nab-paclitaxel + Carboplatin	-1.0	-5.3 – 3.3

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status Secondary · Baseline to Cycle 5; each cycle is 21 days

Least squares mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	2.4	-3.4 – 8.2
Tislelizumab + Nab-paclitaxel + Carboplatin	3.3	-2.5 – 9.2

Number of Participants With Adverse Events Secondary · From first dose to 30 days after the last dose (up to approximately 4 years and 9 months)

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

At least 1 TEAE

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	120
Tislelizumab + Nab-paclitaxel + Carboplatin	117
Paclitaxel + Carboplatin	117

At least 1 SAE

Group	Value	95% CI
Tislelizumab + Paclitaxel + Carboplatin	56
Tislelizumab + Nab-paclitaxel + Carboplatin	55
Paclitaxel + Carboplatin	29

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tislelizumab + Paclitaxel + Carboplatin

Serious: 56/120 (47%)

Deaths: 78/120

Tislelizumab + Nab-Paclitaxel + Carboplatin

Serious: 55/118 (47%)

Deaths: 86/119

Paclitaxel + Carboplatin

Serious: 29/117 (25%)

Deaths: 87/121

Serious adverse events (95 terms)

Reaction	System	Tislelizumab + Paclitaxel …	Tislelizumab + Nab-Paclita…	Paclitaxel + Carboplatin
Pneumonia	Infections and infestations	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—
Neutrophil count decreased	Investigations	—	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Myelosuppression	Blood and lymphatic system disorders	—	—	—
Death	General disorders	—	—	—
Malaise	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Septic shock	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—
Platelet count decreased	Investigations	—	—	—
White blood cell count decreased	Investigations	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	—	—	—
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Hypofibrinogenaemia	Blood and lymphatic system disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Splenic haemorrhage	Blood and lymphatic system disorders	—	—	—

Other adverse events (126 terms — click to expand)

Reaction	System	Tislelizumab + Paclitaxel …	Tislelizumab + Nab-Paclita…	Paclitaxel + Carboplatin
Anaemia	Blood and lymphatic system disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Neutrophil count decreased	Investigations	—	—	—
White blood cell count decreased	Investigations	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Platelet count decreased	Investigations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Asthenia	General disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—
Pyrexia	General disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Lymphocyte count decreased	Investigations	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—
Malaise	General disorders	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—
Weight decreased	Investigations	—	—	—

Most-reported serious reactions: Pneumonia, Pneumonitis, Febrile neutropenia, Neutrophil count decreased, Haemoptysis, Thrombocytopenia, Anaemia, Leukopenia.

Data from ClinicalTrials.gov NCT03594747 adverse events section.

Sponsor's own description

An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced squamous non-small cell lung cancer (NSCLC).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Combination strategies with PD-1/PD-L1 blockade: current advances and future directions.
Yi M, Zheng X, Niu M, Zhu S, et al · · 2022 · cited 1018× · PMID 35062949 · DOI 10.1186/s12943-021-01489-2
Non-small cell lung cancer in China.
Chen P, Liu Y, Wen Y, Zhou C. · · 2022 · cited 479× · PMID 36075878 · DOI 10.1002/cac2.12359
Antibodies to watch in 2020.
Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial.
Wang J, Lu S, Yu X, Hu Y, et al · · 2021 · cited 312× · PMID 33792623 · DOI 10.1001/jamaoncol.2021.0366
Antibodies to watch in 2022.
Kaplon H, Chenoweth A, Crescioli S, Reichert JM. · · 2022 · cited 245× · PMID 35030985 · DOI 10.1080/19420862.2021.2014296
Antibodies to watch in 2023.
Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, et al · · 2023 · cited 204× · PMID 36472472 · DOI 10.1080/19420862.2022.2153410
Reshaping the systemic tumor immune environment (STIE) and tumor immune microenvironment (TIME) to enhance immunotherapy efficacy in solid tumors.
Xu L, Zou C, Zhang S, Chu TSM, et al · · 2022 · cited 131× · PMID 35799264 · DOI 10.1186/s13045-022-01307-2
Signaling pathways and targeted therapies in lung squamous cell carcinoma: mechanisms and clinical trials.
Niu Z, Jin R, Zhang Y, Li H. · · 2022 · cited 127× · PMID 36198685 · DOI 10.1038/s41392-022-01200-x

Verify or expand the search:

Other trials of Tislelizumab

Trials testing the same drug.

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Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

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Other BeiGene trials

Trials by the same sponsor.

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NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum · Phase 2 · active not recruiting
NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB- · Phase 1 · active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants · Phase 1 · completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03594747 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 26 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03594747.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing