Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer (TCL-1)

Shandong University

Status and phase

Unknown

Phase 4

Conditions

Non-Small-Cell Lung Cancer

Treatments

Drug: Docetaxel

Drug: Platinum (cisplatin or carboplatin)

Drug: Gefitinib

Drug: Icotinib

Drug: Pemetrexed

Drug: Erlotinib

Study type

Interventional

Funder types

Other

Identifiers

NCT02031601

QLHX-0531

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Combination therapy

Experimental group

Description:

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)

Treatment:

Drug: Platinum (cisplatin or carboplatin)

Drug: Erlotinib

Drug: Icotinib

Drug: Pemetrexed

Drug: Icotinib

Drug: Gefitinib

Drug: Docetaxel

Drug: Gefitinib

Drug: Erlotinib

TKI alone therapy

Other group