First-line Icotinib With Concurrent Radiotherapy for NSCLC With EGFR Mutation

NCT ID: NCT02883543

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-06-30

Brief 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.

Detailed 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

icotinib plus radiotherapy

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.

Group Type: EXPERIMENTAL

icotinib

Intervention Type: DRUG

Icotinib is orally administered three times per day.

Radiotherapy

Intervention Type: RADIATION

5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.

icotinib

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.

Group Type: ACTIVE_COMPARATOR

icotinib

Intervention Type: DRUG

Icotinib is orally administered three times per day.

chemotherapy plus radiotherapy

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.

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

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

Intervention Type: RADIATION

5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.

Interventions

icotinib

Icotinib is orally administered three times per day.

Intervention Type: DRUG

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

Intervention Type: DRUG

Radiotherapy

5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhen-zhou Yang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenzhou Yang, MD

Role: STUDY_CHAIR

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Other Identifiers

RILI2016

Identifier Type: -

Identifier Source: org_study_id