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

NCT02883543 | Unknown Phase 3 DMC

• 1 other identifier: RILI2016
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  2 years

• Incidence of radiation injure of the lungs

  Measured according to NCI CTCAE v4.0

  2 years

Secondary Outcomes (3)

• Overall survival

  5 years

• Tumor response after icotinib induction

  8 weeks

• Quality of life

  2 years

Study Arms (3)

icotinib plus radiotherapy

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.

Drug: icotinib; Radiation: Radiotherapy

icotinib

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.

Drug: icotinib

chemotherapy plus radiotherapy

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.

Drug: Chemotherapy; Radiation: Radiotherapy

Interventions

icotinib DRUG

Icotinib is orally administered three times per day.

icotinib; icotinib plus radiotherapy

Chemotherapy 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

chemotherapy plus radiotherapy

Radiotherapy RADIATION

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

chemotherapy plus radiotherapy; icotinib plus radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhenzhou Yang, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 30, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share