Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03777124
Phase
PHASE2
Status
Terminated

Conditions

  • Chemotherapy Effect
  • KRAS Gene Mutation
  • NSCLC Stage IV
  • PD-1 Antibody

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-1210 — DRUG
    Subjects receive SHR-1210 intravenous every 2 weeks
  • Apatinib — DRUG
    Subjects receive Apatinib orally every day
  • Pemetrexed — DRUG
    Subjects receive Pemetrexed intravenous every 3 weeks
  • Carboplatin — DRUG
    subjects receive carboplatin intravenous every 3 weeks

Study Details

This is a randomized, open-label, multi-center, phase II trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus Pemetrexed and Carboplatin in Subjects with KRAS mutant stage IV non-squamous Non-small Cell Lung Cancer

Key Dates

Start date
Jul 11, 2019
Status verified
Jul 2025
Primary completion
Jun 29, 2023
Completion
Jun 29, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-1210 +apatinib
    subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day
  • Active Comparator: chemotherapy
    Pemetrexed 500mg/m2, Day 1 of each 21 day, 4 cycles carboplatin AUC 5 on Day 1 of each 21 day, 4 cycles followed by pemetrexed 500mg/m2 until progression Q3W

Primary Outcome Measure

Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1 [ Time Frame: up to approximately 40 months ]

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