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

NCT02883543 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2016-08-30

No results posted yet for this study

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

Interventions

DRUG

icotinib

Icotinib is orally administered three times per day.

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Zhenzhou Yang, MD · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-06-30
Completion
2019-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02883543 on ClinicalTrials.gov