Tislelizumab Combined With Chemotherapy With or Without Bevacizumab in TKI-Resistant EGFR-Mutated Non-squamous NSCLC
NCT04405674 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2021-11-22
Summary
A phase II, open-label, multicenter, two cohorts, prospective clinical study to investigate the efficacy and safety of tislelizumab (anti-pd1 antibody) combined with chemotherapy with or without bevacizumab in non-squamous non-small cell lung cancer patients with EGFR sensitizing mutation who failed EGFR TKI (Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor) therapy.
Conditions
- Non Small Cell Lung Cancer
Interventions
- DRUG
-
Tislelizumab
Tislelizumab 200mg administered intravenously (IV) on Day 1 of each 21-day cycle
- DRUG
-
Carboplatin AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles
- DRUG
-
Pemetrexed
Pemetrexed 500mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle
- DRUG
-
Bevacizumab 7.5mg/kg administered intravenously (IV) on Day 1 of each 21-day cycle
- DRUG
-
Nab paclitaxel
Nab-paclitaxel 260mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles
Sponsors & Collaborators
-
Shanghai Chest Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-15
- Primary Completion
- 2022-04-30
- Completion
- 2025-03-31
Countries
- China
Study Locations
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