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

• ClinicalTrials.gov Identifier: NCT02883543
• Recruitment Status: Unknown
• First Posted: August 30, 2016
• Last Update Posted: August 30, 2016
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Information provided by (Responsible Party): Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer	Drug: icotinib; Drug: Chemotherapy; Radiation: Radiotherapy	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: June 2016
• Estimated Primary Completion Date: June 2018
• Estimated Study Completion Date: June 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: icotinib; Icotinib is orally administered three times per day.; Radiation: Radiotherapy; 5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.
Active Comparator: 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.	Drug: icotinib; Icotinib is orally administered three times per day.
Active Comparator: 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.	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; Radiation: Radiotherapy; 5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.

Outcome Measures

Primary Outcome Measures :

1. Progression-free survival [ Time Frame: 2 years ]
2. Incidence of radiation injure of the lungs [ Time Frame: 2 years ]
   Measured according to NCI CTCAE v4.0

Secondary Outcome Measures :

1. Overall survival [ Time Frame: 5 years ]
2. Tumor response after icotinib induction [ Time Frame: 8 weeks ]
3. Quality of life [ Time Frame: 2 years ]
   Measured by FACT-L

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

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

Investigators

• Study Chair: Zhenzhou Yang, MD; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

More Information

• Responsible Party: Zhen-zhou Yang, Director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• ClinicalTrials.gov Identifier: NCT02883543
• Other Study ID Numbers: RILI2016
• First Posted: August 30, 2016
• Last Update Posted: August 30, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases