Clinical trial · Interventional

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

A Phase 3, Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Paclitaxel Plus Carboplatin or Nab Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line Treatment for Untreated Advanced Squamous Non-small Cell Lung Cancer

NCT03594747CI-TRIAL-00081942completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non-Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Carboplatin	Drug	Carboplatin	ALIAS
Nab-paclitaxel	Drug	Nab-paclitaxel	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS
Tislelizumab	Drug	Tislelizumab	ALIAS

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Tislelizumab + Paclitaxel + Carboplatin
description
Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
interventionNames
1. Drug: Tislelizumab
2. Drug: Paclitaxel
3. Drug: Carboplatin
type
EXPERIMENTAL
label
Tislelizumab + Nab-paclitaxel + Carboplatin
description
Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Key Inclusion Criteria:

1. Age 18-75 years old, male or female, and signed informed consent form (ICF)
2. Advanced NSCLC diagnosed by pathological or clinical physicians
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
4. Participants must have ≥ 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5. Must be treatment-naive for locally advanced or metastatic squamous NSCLC
6. Life expectancy ≥ 12 weeks
7. Participants must have adequate organ function
8. Male/Female is willing to use a highly effective method of birth control

Key Exclusion Criteria:

1. Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
2. Received any approved systemic anticancer therapy
3. Received prior treatment with EGFR inhibitors or ALK inhibitors
4. Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
5. With history of interstitial lung disease
6. Clinically significant pericardial effusion
7. Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
8. Any major surgical procedure before randomization
9. Human immunodeficiency virus infection
10. Untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)
11. Active autoimmune diseases or history of autoimmune diseases
12. History of allergic reactions to chemotherapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

References

Publications (4)

BACKGROUNDWang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. doi: 10.1001/jamaoncol.2021.0366. PMID 33792623
BACKGROUNDWang, J, S. Lu, et al. Randomized Phase III Study of Tislelizumab plus Chemotherapy versus Chemotherapy Alone as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer (Sq-NSCLC): RATIONALE-307 Updated Analysis. IOTECH Abstract, Vol. 16 Supplement 1, Dec. 2022. doi.org/10.1016/j.iotech.2022.100244.
DERIVEDWang Z, Yu X, Zhao J, Yu Y, Wu J, Ma R, Ma Z, Cui J, Zhang J, Bao Y, Leaw S, Wang J. First-Line Tislelizumab Plus Chemotherapy for Advanced or Metastatic Squamous Non-Small Cell Lung Cancer: 4-Year Long-Term Follow-Up from RATIONALE-307. Oncol Ther. 2026 Jun;14(2):811-825. doi: 10.1007/s40487-026-00424-z. Epub 2026 Mar 11. PMID 41811656
DERIVEDDuan J, Zhang Y, Chen R, Liang L, Huo Y, Lu S, Zhao J, Hu C, Sun Y, Yang K, Chen M, Yu Y, Ying J, Huang R, Ma X, Leaw S, Bai F, Shen Z, Cai S, Gao D, Wang J, Wang Z. Tumor-immune microenvironment and NRF2 associate with clinical efficacy of PD-1 blockade combined with chemotherapy in lung squamous cell carcinoma. Cell Rep Med. 2023 Dec 19;4(12):101302. doi: 10.1016/j.xcrm.2023.101302. Epub 2023 Dec 4. PMID 38052215

Registry

Dates and enrollment

Start: Jul 30, 2018
Primary completion: Sep 30, 2020
Completion: Apr 28, 2023
First posted: Jul 20, 2018
Last update posted: Oct 26, 2024
Results first posted: Oct 17, 2023
Enrollment: 360 (actual)
Lead sponsor: BeiGene INDUSTRY

Data updated 22 days agoSource updated Oct 26, 2024source: clinicaltrials

Locations

Locations by country (43)

Country	Sites	Recruiting
China	43	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.