Clinical trial · Interventional

Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Etoposide With or Without Tislelizumab (BGB-A317) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

NCT04005716CI-TRIAL-00086584completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This Phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy of tislelizumab in combination with either cisplatin or carboplatin and etoposide (Arm A), compared to placebo combined with either cisplatin or carboplatin and etoposide (Arm B), as a first-line treatment for participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

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
Small Cell Lung Cancer	Lung Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Carboplatin	Drug	Carboplatin	ALIAS
Cisplatin	Drug	Cisplatin	ALIAS
Etoposide	Drug	Etoposide	ALIAS
Placebo	Drug	—	UNRESOLVED
Tislelizumab	Drug	Tislelizumab	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm A: Tislelizumab + Chemotherapy
description
Participants received tislelizumab in combination with either cisplatin or carboplatin (at the investigator's discretion) and etoposide during the induction phase, administered every 3 weeks for 4 cycles. Upon completion of the induction phase, participants transitioned to maintenance therapy with tislelizumab only, administered once every 3 weeks.
interventionNames
1. Drug: Tislelizumab
2. Drug: Cisplatin
3. Drug: Carboplatin
4. Drug: Etoposide
type
PLACEBO_COMPARATOR
label
Arm B: Placebo + Chemotherapy
description
Participants received a placebo in combination with either cisplatin or carboplatin (at the investigator's discretion) and etoposide during the induction phase, given every 3 weeks for 4 cycles. Upon completion of the induction phase, participants transitioned to maintenance therapy with placebo only, administered once every 3 weeks.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Key Inclusion Criteria:

1. Age≥18 years old, male or female, signed Informed Consent Form (ICF).
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Histologically or cytologically confirmed ES-SCLC
4. No prior systemic treatment for ES-SCLC
5. Adequate hematologic and end organ function

Key Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
3. Was administered a live vaccine ≤ 4 weeks before randomization;
4. Active autoimmune diseases or history of autoimmune diseases that may relapse
5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization;
6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to randomization, including but not limited to tuberculosis infection;
8. Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV), or a known history of HIV infection;
9. Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization;
10. Clinically significant pericardial effusion, or Clinically uncontrolled pleural effusion

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

References

Publications (5)

RESULTCheng Y, Fan Y, Zhao Y, Huang D, Li X, Zhang P, Kang M, Yang N, Zhong D, Wang Z, Yu Y, Zhang Y, Zhao J, Qin T, Chen C, Leaw S, Zheng W, Song Y; RATIONALE-312 Study Group. Tislelizumab Plus Platinum and Etoposide Versus Placebo Plus Platinum and Etoposide as First-Line Treatment for Extensive-Stage SCLC (RATIONALE-312): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 3 Clinical Trial. J Thorac Oncol. 2024 Jul;19(7):1073-1085. doi: 10.1016/j.jtho.2024.03.008. Epub 2024 Mar 7. PMID 38460751
DERIVEDFan Y, Zhao Y, Huang D, Zhao J, Qin T, He W, Chen C, Sun P, Naicker K, Song Y; RATIONALE-312 Study Group. First-Line Tislelizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Extensive-Stage SCLC: A Long-Term Survival and Programmed Death-Ligand 1 Subgroup Analysis From the Randomized, Phase 3 RATIONALE-312 Trial. J Thorac Oncol. 2026 Jun;21(6):103655. doi: 10.1016/j.jtho.2026.103655. Epub 2026 Mar 6. PMID 41796863
DERIVEDCheng Y, Qin T, Chen C, B Barnes F, Barnes G. Tislelizumab plus platinum and etoposide versus placebo plus platinum and etoposide as first-line treatment for extensive-stage small-cell lung cancer: patient-reported outcomes in the RATIONALE-312 trial. Curr Med Res Opin. 2025 Dec;41(12):2357-2367. doi: 10.1080/03007995.2026.2620691. Epub 2026 Jan 30. PMID 41614649
DERIVEDLong R, Chen F. First-line chemotherapy with tislelizumab for patients with extensive-stage small cell lung cancer: a cost-effectiveness analysis. Sci Rep. 2024 Dec 30;14(1):31958. doi: 10.1038/s41598-024-83509-x. PMID 39738721
DERIVEDWu J, Zhang A, Li L, Liu S, Yang F, Yang R. Meta-analysis of the Efficacy and Tolerability of Immune Checkpoint Inhibitors Combined With Chemotherapy in First-line Treatment of Small Cell Lung Cancer. Clin Ther. 2021 Mar;43(3):582-593.e2. doi: 10.1016/j.clinthera.2020.12.017. Epub 2021 Jan 25. PMID 33509647

Registry

Dates and enrollment

Start: Jul 22, 2019
Primary completion: Apr 19, 2023
Completion: Dec 29, 2023
First posted: Jul 2, 2019
Last update posted: Feb 28, 2025
Results first posted: Feb 28, 2025
Enrollment: 457 (actual)
Lead sponsor: BeiGene INDUSTRY

Data updated 22 days agoSource updated Feb 28, 2025source: clinicaltrials

Locations

Locations by country (50)

Country	Sites	Recruiting
China	50	0

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