Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments icotinib, chemotherapy, radiotherapy
Phase phase 3
Target EGFR
Sponsor Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Start date June 2016
End date June 2018
Trial size 330 participants
Trial identifier NCT02883543, RILI2016

Summary

Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy.
icotinib
Icotinib is orally administered three times per day.
radiotherapy
5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.
(Active Comparator)
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib monotherapy.
icotinib
Icotinib is orally administered three times per day.
(Active Comparator)
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive chemotherapy plus concurrent radiotherapy.
chemotherapy
Chemotherapy is given by intravenous administration. Three regimens are available in this study. Regimen 1: etoposide 75mg/m2 d1-5 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 2: docetaxel 75mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 3: pemetrexed 500mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2
radiotherapy
5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.

Primary Outcomes

Measure
Progression-free survival
time frame: 2 years
Incidence of radiation injure of the lungs
time frame: 2 years

Secondary Outcomes

Measure
Overall survival
time frame: 5 years
Tumor response after icotinib induction
time frame: 8 weeks
Quality of life
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Aged 18 to 75 years - Pathologically documented NSCLC - Unresectable stage III or oligometastasis (less than three metastasis lesions, brain metastasis is not permitted) stage IV confirmed by CT and/or MRI - Positive EGFR mutation confirmed by ARMS - At least 3-month life expectancy - KPS ≥ 70 - Adequate hematological values: hemoglobin ≥ 100 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L - Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN - Written informed consent before patient registration and any protocol-related procedures Exclusion Criteria: - Previous radiotherapy - Received other investigational systemic drugs within 4 weeks prior to study entry - Severe or uncontrolled systemic disease - Active autoimmune disease, or a documented history of autoimmune/acquired immune disease, or a history of organ transplant - Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator - Any other serious underlying medical (e.g. active uncontrolled infection, active gastric ulcer, uncontrolled seizures), psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Additional Information

Official title Phase III Study of Icotinib With Concurrent Radiotherapy as First-line Treatment for Unresectable/Oligometastasis NSCLC With EGFR Activating Mutation: a Prospective, Multicentre, Open-label, Randomised Study
Description Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy. The primary endpoint is progression-free survival, and the incidence of radiation-induced lung injury.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.