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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Hospital; Qilu Hospital of Shandong University
• Treatments: Carboplatin; Cisplatin; Docetaxel; Erlotinib Hydrochloride; Gefitinib; Pemetrexed

Criteria

Inclusion Criteria:

• Adult patients, >=18 years of age;

• Advanced (stage IIIB/IV) non-small-cell lung cancer;

• Although stageⅠ-ⅢA, have contraindications to surgery;

• EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21);

• Measurable disease;

• ECOG Performance Status 0 or 1 or 2.

Exclusion Criteria:

• Wild-type EGFR;

• Prior exposure to agents directed at the HER axis;

• Prior chemotherapy or systemic anti-tumor therapy after advanced disease;

• Unstable systemic disease;

• Any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;

• Brain metastasis or spinal cord compression.