Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer

Sponsor
Qilu Hospital of Shandong University
Study ID
NCT02031601
Phase
PHASE4
Status
Unknown

Conditions

  • Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    150mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive erlotinib150mg po once a day daily until progression
  • Gefitinib — DRUG
    250mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive gefitinib 250mg po once a day daily until progression
  • Icotinib — DRUG
    125mg po three time a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive icotinib 125mg po three time a day daily until progression
  • Docetaxel — DRUG
    75 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
  • Pemetrexed — DRUG
    500 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
  • Platinum (cisplatin or carboplatin) — DRUG
    cisplatin -- 75mg/m2 ivgtt on day 1 of each 3 week cycle for 4 cycles or carboplatin -- 5 x AUC ivgtt on day 1 of each 3 week cycle for 4 cycles
  • Erlotinib — DRUG
    150mg po once a day daily until disease progression
  • Gefitinib — DRUG
    250mg po once a day daily until disease progression
  • Icotinib — DRUG
    125mg po three times a day daily until disease progression

Study Details

Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment for patients with non-small-cell lung cancer (NSCLC). Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be randomly assigned to combination therapy group (receiving four cycles of docetaxel or pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib or Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or Icotinib, daily). All patients were continued to receive TKI until progression or unacceptable to toxicity or death. The primary endpoint was progression-free survivial (PFS). Expected results: PFS of combination therapy group will be prolonged to nineteen months while PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination therapy group will be prolonged to 36 months while OS of TKI alone therapy group is 26 months. Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as first-line treatment will prolong PFS and OS for patients with NSCLC.

Key Dates

First listed
Jan 9, 2014
Start date
Jan 31, 2014
Status verified
Nov 2015
Primary completion
Dec 31, 2016
Completion
Dec 31, 2017

Study Design

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

Arms

  • Experimental: Combination therapy
    Interventions: Drug: Erlotinib \[Tarceva\] or Gefitinib \[Iressa\] or Icotinib \[Conmana\] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin)
  • Other: TKI alone therapy
    Interventions: Drug: Erlotinib \[Tarceva\] or Gefitinib \[Iressa\] or Icotinib \[Conmana\]

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 8 weeks ]

Central Contacts

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