Tislelizumab Combined With Chemotherapy With or Without Bevacizumab in TKI-Resistant EGFR-Mutated Non-squamous NSCLC

Sponsor
Shanghai Chest Hospital
Study ID
NCT04405674
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    Tislelizumab 200mg administered intravenously (IV) on Day 1 of each 21-day cycle
  • Carboplatin — DRUG
    Carboplatin AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles
  • Pemetrexed — DRUG
    Pemetrexed 500mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle
  • Bevacizumab — DRUG
    Bevacizumab 7.5mg/kg administered intravenously (IV) on Day 1 of each 21-day cycle
  • Nab paclitaxel — DRUG
    Nab-paclitaxel 260mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles

Study Details

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.

Key Dates

First listed
May 28, 2020
Start date
Jul 15, 2020
Status verified
Nov 2021
Primary completion
Apr 30, 2022
Completion
Mar 31, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tislelizumab plus chemotherapy
    Tislelizumab plus Carboplatin/Nab-paclitaxel as induction treatment and followed by Tislelizumab plus pemetrexed as maintenance treatment.
  • Experimental: Tislelizumab plus chemotherapy plus Bevacizumab
    Tislelizumab plus Nab-paclitaxel and Bevacizumab as induction treatment and followed by Tislelizumab plus Bevacizumab as maintenance treatment.

Primary Outcome Measure

1-Year Progression-Free Survival Rate (1-Year PFS Rate) [ Time Frame: up to 24 months after enrollment or study close ]

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