Clinical trial · Interventional
Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)
A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen
- 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)
The purpose of this study is to show that tislelizumab will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tislelizumab
- description
- Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
- interventionNames
- Drug: Tislelizumab
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- description
- Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
- interventionNames
- Drug: Docetaxel
Primary outcomes (2)
- measure
- Overall Survival (OS) in All Participants (Co-primary Endpoint)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Age ≥ 18 years. 2. Signed Informed Consent Form. 3. Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC of either squamous or non-squamous histology types with disease progression during or following treatment with at least one platinum-containing regimen, but no more than 2 lines of systemic therapy. 4. Participants must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells. Participants with non-squamous histology must provide evidence of not harboring sensitizing epidermal growth factor (EGFR) mutation tested by a histology-based method. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 6. Adequate hematologic and end-organ function. 7. Expected life span \> 12 weeks. 8. Willing to be compliance with birth control requirement during pre-specified study participating period Key Exclusion Criteria: 1. Prior therapies of docetaxel or treatment targeting programmed cell death protein 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte associated protein 4 (CTLA-4). 2. Harboring EGFR sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation. 3. Unresolved side effects of Grade 2 and above from prior anti-cancer therapies, except for adverse events (AEs) not constituting a likely safety risk (e.g. alopecia, rash, pigmentation, specific lab abnormalities). 4. History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs). 5. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline. 6. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment. 7. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 8. Severe chronic or active infection requiring systemic treatment. 9. Known human immunodeficiency virus (HIV) infection, participants with untreated chronic hepatitis B, active vaccination treatment. 10. Insufficient cardiac functions and other underlying unfavorable cardiovascular conditions. 11. Prior allogeneic stem cell transplantation or organ transplantation. 12. Active autoimmune diseases or history of autoimmune diseases that may relapse. 13. With conditions requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications. 14. With severe underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse that may affect the explanation of drug toxicity or AEs or result in impaired compliance with study conduct. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (3)
- RESULTZhou C, Huang D, Fan Y, Yu X, Liu Y, Shu Y, Ma Z, Wang Z, Cheng Y, Wang J, Hu S, Liu Z, Poddubskaya E, Disel U, Akopov A, Dvorkin M, Zheng W, Ma Y, Wang Y, Li S, Yu C, Rivalland G. Tislelizumab Versus Docetaxel in Patients With Previously Treated Advanced NSCLC (RATIONALE-303): A Phase 3, Open-Label, Randomized Controlled Trial. J Thorac Oncol. 2023 Jan;18(1):93-105. doi: 10.1016/j.jtho.2022.09.217. Epub 2022 Sep 29. PMID 36184068
- RESULTHuang D, Zhou C, Barnes G, Ma Y, Li S, Zhan L, Tang B. The effects of tislelizumab treatment on the health-related quality of life of patients with advanced non-small cell lung cancer. Cancer Med. 2023 Aug;12(16):17403-17412. doi: 10.1002/cam4.6361. Epub 2023 Aug 17. PMID 37587845
- DERIVEDde Marchi P, Fan Y, Ma Z, Wang Y, Bao Y, Zheng W, Naicker K, Zhou C. RATIONALE-303: Long-Term Outcomes of Tislelizumab in Previously Treated Advanced/Metastatic NSCLC. JTO Clin Res Rep. 2026 Jun 1;7(8):101028. doi: 10.1016/j.jtocrr.2026.101028. eCollection 2026 Aug. PMID 42529140