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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02883543
Recruitment Status : Unknown
Verified August 2016 by Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was:  Active, not recruiting
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

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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

Resource links provided by the National Library of Medicine


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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883543


Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
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Study Chair: Zhenzhou Yang, MD Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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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    Key Record Dates
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:
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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