Phase 3
Completed N=360
A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
Source: ClinicalTrials.gov NCT03594747 ↗Enrolled (actual)
360
Serious AEs
39.4%
Results posted
Oct 2023
Primary outcomePrimary: Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 — 7.6; 7.6; 5.5 Months — p=0.0001
◆ Published Evidence
Highly cited
398citations · ~80 / year
Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial.
Summary
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).
Linked Publications (3)
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Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial.
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Tumor-immune microenvironment and NRF2 associate with clinical efficacy of PD-1 blockade combined with chemotherapy in lung squamous cell carcinoma.
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First-Line Tislelizumab Plus Chemotherapy for Advanced or Metastatic Squamous Non-Small Cell Lung Cancer: 4-Year Long-Term Follow-Up from RATIONALE-307.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 |
7.6; 7.6; 5.5 | 0.0001 sig |
| PRIMARY PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020 |
7.7; 9.6; 5.5 | — |
| SECONDARY Overall Survival (OS) |
26.1; 23.3; 19.4 | — |
| SECONDARY Objective Response Rate (ORR) by IRC Assessment |
74.2; 73.9; 47.9 | — |
| SECONDARY ORR by Investigator Assessment |
70.0; 78.2; 49.6 | — |
| SECONDARY Duration of Response (DOR) by IRC Assessment |
8.4; 8.6; 4.3 | — |
| SECONDARY DOR by Investigator Assessment |
10.6; 8.8; 4.8 | — |
| SECONDARY PFS by Investigator Assessment |
9.6; 9.8; 5.5 | — |
| SECONDARY PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression |
7.6; 7.6; 5.5; 9.9; 9.8; 5.0 | — |
| SECONDARY European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) |
0.4; -0.4; -7.0; -0.4; -2.7; -1.0 | — |
| SECONDARY European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status |
2.4; 3.3 | — |
| SECONDARY Number of Participants With Adverse Events |
120; 117; 117; 56; 55; 29 | — |
Eligibility Criteria
Key Inclusion Criteria
- Age 18-75 years old, male or female, and signed informed consent form (ICF)
- Advanced NSCLC diagnosed by pathological or clinical physicians
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- Participants must have ≥ 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Must be treatment-naive for locally advanced or metastatic squamous NSCLC
- Life expectancy ≥ 12 weeks
- Participants must have adequate organ function
- Male/Female is willing to use a highly effective method of birth control
Key Exclusion Criteria
- Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
- Received any approved systemic anticancer therapy
- Received prior treatment with EGFR inhibitors or ALK inhibitors
- Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
- With history of interstitial lung disease
- Clinically significant pericardial effusion
- Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any major surgical procedure before randomization
- Human immunodeficiency virus infection
- Untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)
- Active autoimmune diseases or history of autoimmune diseases
- History of allergic reactions to chemotherapy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03594747) 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.