Phase 3
Completed N=457
Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT04005716 ↗Enrolled (actual)
457
Serious AEs
36.0%
Results posted
Feb 2025
Primary outcomePrimary: Overall Survival (OS) — 15.5; 13.5 Months — p=0.0040
◆ Published Evidence
Highly cited
132citations · ~66 / year
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.
Summary
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).
Linked Publications (5)
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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.
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Meta-analysis of the Efficacy and Tolerability of Immune Checkpoint Inhibitors Combined With Chemotherapy in First-line Treatment of Small Cell Lung Cancer.
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First-line chemotherapy with tislelizumab for patients with extensive-stage small cell lung cancer: a cost-effectiveness analysis.
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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.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
15.5; 13.5 | 0.0040 sig |
| SECONDARY Progression Free Survival (PFS) |
4.7; 4.3 | <0.0001 sig |
| SECONDARY Overall Response Rate (ORR) |
68.3; 61.7 | — |
| SECONDARY Disease Control Rate (DCR) |
88.5; 88.3 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
69.2; 65.2 | — |
| SECONDARY Duration of Response (DOR) |
4.3; 3.7 | — |
| SECONDARY Number of Participants With Adverse Events |
226; 228; 94; 70 | — |
| 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. |
8.9; 4.5; 11.3; 4.2; 0.6; 0.4 | — |
| 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 |
-19.5; -16.0; -18.6; -16.7; -2.5; -3.1 | — |
| SECONDARY Time to Deterioration (TTD) |
NA; NA; NA; NA; NA; NA | — |
Eligibility Criteria
Key Inclusion Criteria
- Age≥18 years old, male or female, signed Informed Consent Form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed ES-SCLC
- No prior systemic treatment for ES-SCLC
- Adequate hematologic and end organ function
Key Exclusion Criteria
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
- 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;
- Was administered a live vaccine ≤ 4 weeks before randomization;
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization;
- With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
- 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;
- Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV), or a known history of HIV infection;
- Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization;
- Clinically significant pericardial effusion, or Clinically uncontrolled pleural effusion
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04005716) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.