Phase 3
N=334
A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous Non-small Cell Lung Cancer
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03663205 ↗Enrolled (actual)
334
Serious AEs
37.4%
Results posted
Nov 2024
Primary outcome: Primary: Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment — 9.7; 7.6 Months — p=0.0054
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tislelizumab (Drug); Cisplatin (Drug); Carboplatin (Drug); Pemetrexed (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment |
9.7; 7.6 | 0.0054 sig |
| SECONDARY Objective Response Rate (ORR) by IRC Assessment |
57.8; 36.9 | — |
| SECONDARY Duration of Response (DOR) by IRC Assessment |
10.6; 7.0 | — |
| SECONDARY Overall Survival (OS) |
21.4; 20.1 | — |
| SECONDARY PFS by Investigator Assessment |
9.7; 5.6 | — |
| SECONDARY ORR by Investigator Assessment |
57.4; 36.0 | — |
| SECONDARY DOR by Investigator Assessment |
14.5; 8.4 | — |
| SECONDARY Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) |
-13.0; -10.8; -1.4; -0.3; -7.4; -4.2 | — |
| SECONDARY Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status |
0.9; -3.0 | — |
| SECONDARY Number of Participants With Adverse Events |
222; 109; 99; 25 | — |
| SECONDARY PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression |
7.6; 7.6; 9.7; 9.7; 17.2; 4.6 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Age 18-75 years old, male or female, signed informed consent form
- Advanced NSCLC diagnosed by pathological or clinical physicians
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
- Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1
- Participants must have no prior systemic chemotherapy for advanced or metastatic NSCLC
- Life expectancy ≥ 12 weeks
- Participants must have adequate organ function
- Male/female is willing to use a highly effective method of birth control
Exclusion Criteria
- Diagnosed with NSCLC but with epidermal growth factor receptor (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
- Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment
- Received prior treatment with EGFR inhibitors or ALK inhibitors
- Received prior therapies targeting programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (PD-L1)
- With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases
- Clinically significant pericardial effusion
- Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any major surgical procedure ≤ 28 days before randomization
- Human immunodeficiency virus (HIV) infection
- Participants with untreated hepatitis B or C virus (HBV/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 (NCT03663205). 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.