Apatinib Combine With Platinum-Based Doublet Chemotherapy for First-line Treatment of Advanced NSCLC

Sponsor
West China Hospital
Study ID
NCT03201146
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    Doses to be determined following the completion of Phase I of the study.
  • AP or AC — DRUG
    Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
  • Apatinib 250mg — DRUG
    250mg/d,q.d.,p.o.every 21 days.
  • Apatinib 500mg — DRUG
    500mg/d,q.d.,p.o.every 21 days.
  • Apatinib 750mg — DRUG
    750mg/d,q.d.,p.o.every 21 days.

Study Details

The purpose of this study is to evaluate the safety and clinical activity of Apatinib in combination with AP(Pemetrexed/Carboplatin) or AC(Pemetrexed/Carboplatin) as first-line chemotherapy in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer(NSCLC).

Key Dates

Start date
Jun 27, 2017
Status verified
Nov 2017
Primary completion
Jul 1, 2020
Completion
Aug 1, 2020

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib 750mg + AP or AC
    Phase 1 study of Apatinib in combination with platinum-based doublet chemotherapy.
  • Experimental: Apatinib 500mg + AP or AC
    Phase 1 study of Apatinib in combination with platinum-based doublet chemotherapy.
  • Experimental: Apatinib 250mg + AP or AC
    Phase 1 study of Apatinib in combination with platinum-based doublet chemotherapy(PBDC).
  • Experimental: Apatinib
    Phase 2 study of Apatinib in combination with platinum-based doublet chemotherapy(PBDC).
  • Active Comparator: AP or AC
    Pemetrexed/Cisplatin(AP) or Pemetrexed/Carboplatin(AC), The platinum-based doublet chemotherapy, as the control group in the phase 2 study.

Primary Outcome Measure

Objective response rate(ORR) [ Time Frame: Up to 36 months ]

Central Contacts

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