Tislelizumab +Bevacizumab+pc for Untreated EGFR+ and High PD-L1 Non-squamous NSCLC

Sponsor
Sichuan Cancer Hospital and Research Institute
Study ID
NCT05394233
Phase
PHASE2
Status
Unknown

Conditions

  • EGFR Gene Mutation
  • Non-squamous Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed — DRUG
    Bevacizumab: 7.5 mg/kg administered as an intravenous infusion on Day 1 of each 3-week cycle Cisplatin 75 mg/m2 will be administered as an intravenous infusion over 2 hours, every 3 weeks, Pemetrexed, 500 mg/m2, intravenously every 3 weeks, Tislelizumab, 200 mg IV every 3 weeks

Study Details

A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study

Key Dates

First listed
May 27, 2022
Start date
Jun 1, 2022
Status verified
May 2022
Primary completion
Dec 1, 2023
Completion
Jun 1, 2024

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: tislelizumab combined with bevacizumab and platinum plus pemetrexed
    Drug: Induction Phase: Bevacizumab: 7.5 mg/kg administered as an IV infusion on Day 1 of each 3-week cycle for 4 cycles Cisplatin 75 mg/m2 will be administered as an intravenous infusion over 2 hours every 3 weeks for 4 cycles. Pemetrexed, 500 mg/m2, intravenously, every 3 weeks for 4 cycles Maintenance phase: Tislelizumab, 200 mg IV every 3 weeks;until disease progression or intolerance Bevacizumab: 7.5 mg/kg administered as an intravenous infusion on Day 1 of each 3-week cycle;until disease progression or intolerance

Primary Outcome Measure

middle progression free survival [ Time Frame: Estimated about 6 months ]

Central Contacts

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