Clinical trial · Interventional
A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous Non-small Cell Lung Cancer
A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Patients With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with Stage IIIB or IV non-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 |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tislelizumab + Platinum + Pemetrexed
- description
- Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
- interventionNames
- Drug: Tislelizumab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Pemetrexed
- type
- ACTIVE_COMPARATOR
- label
- Platinum + Pemetrexed
- description
- Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
- interventionNames
- Drug: Cisplatin
- Drug: Carboplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years old, male or female, signed informed consent form 2. Advanced NSCLC diagnosed by pathological or clinical physicians 3. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1 4. Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1 5. Participants must have no prior systemic chemotherapy for advanced or metastatic 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 Exclusion Criteria: 1. Diagnosed with NSCLC but with epidermal growth factor receptor (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation 2. Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment 3. Received prior treatment with EGFR inhibitors or ALK inhibitors 4. Received prior therapies targeting programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (PD-L1) 5. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases 6. Clinically significant pericardial effusion 7. Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis 8. Any major surgical procedure ≤ 28 days before randomization 9. Human immunodeficiency virus (HIV) infection 10. Participants with untreated hepatitis B or C virus (HBV/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 (3)
- RESULTLu S, Wang J, Yu Y, Yu X, Hu Y, Ai X, Ma Z, Li X, Zhuang W, Liu Y, Li W, Cui J, Wang D, Liao W, Zhou J, Wang Z, Sun Y, Qiu X, Gao J, Bao Y, Liang L, Wang M. Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. J Thorac Oncol. 2021 Sep;16(9):1512-1522. doi: 10.1016/j.jtho.2021.05.005. Epub 2021 May 23. PMID 34033975
- DERIVEDLu S, Wang J, Yu Y, Yu X, Hu Y, Wangjun L, Li X, Liu Y, Li W, Qu X, Bao Y, Wang M. First-Line Tislelizumab Plus Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer: PD-L1 >/= 50% Subgroup Analysis from the RATIONALE-304 Trial. Oncol Ther. 2025 Dec;13(4):1087-1104. doi: 10.1007/s40487-025-00378-8. Epub 2025 Sep 14. PMID 40946254
- DERIVEDLu S, Yu Y, Barnes G, Qiu X, Bao Y, Tang B. Examining the Impact of Tislelizumab Added to Chemotherapy on Health-Related Quality-of-Life Outcomes in Previously Untreated Patients With Nonsquamous Non-Small Cell Lung Cancer. Cancer J. 2022 Mar-Apr 01;28(2):96-104. doi: 10.1097/PPO.0000000000000583. PMID 35333492