A Study of Gefitinib With or Without Apatinib in Patients With Advanced Non-squamous Non-Small-Cell Lung Cancer Harboring EGFR Mutations

Sponsor
Sun Yat-sen University
Study ID
NCT02824458
Phase
PHASE3
Status
Unknown

Conditions

  • EGFR Tyrosine Kinase Inhibitors Plus VEGFR Inhibitors

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    Patients will be treated with Apatinib, 250/500/750 mg(dose determined from Part A of study) p.o., daily
  • Gefitinib — DRUG
    Patients will be treated with Gefitinib, 250 mg p.o., daily
  • Placebo — DRUG

Study Details

The main purpose of this study is to evaluate the safety and efficacy of Apatinib in combination with Gefitinib as compared to placebo in combination with Gefitinib in participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).

Key Dates

Start date
Jun 30, 2016
Status verified
Jul 2016
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

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

Arms

  • Experimental: Gefitinib + Apatinib
    (Part A) Phase I, Open-label, Dose-escalation Study Escalating doses(500mg, 750mg, or 250mg) of Apatinib in combination with 250mg Gefitinib daily orally. Participants may continue to receive treatment until progress or intolerable. (Part B)Multicenter, Randomized, Double-Blind Study Apatinib (dose determined from Part A of study) in combination with 250mg Gefitinib.
  • Placebo Comparator: Gefitinib + Placebo
    (Part A) Not Applicable (Part B) Placebo in combination with 250mg Gefitinib. Participants may continue to receive treatment until progress or intolerable.

Primary Outcome Measure

(Part A) Determine Dose-Limiting Toxicity (DLT) of Apatinib in combination with Gefitinib [ Time Frame: 1 months ]

Central Contacts