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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02883543
• Other study ID #: RILI2016
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 8, 2016
• Last updated: August 29, 2016
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: August 2016
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• icotinib
Icotinib is orally administered three times per day.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		2 years	No
Primary	Incidence of radiation injure of the lungs	Measured according to NCI CTCAE v4.0	2 years	Yes
Secondary	Overall survival		5 years	No
Secondary	Tumor response after icotinib induction		8 weeks	No
Secondary	Quality of life	Measured by FACT-L	2 years	No