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Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation

NCT02448797 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2021-07-20

No results posted yet for this study

Summary

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.

Conditions

Interventions

DRUG

Icotinib

125 mg three times daily (375 mg per day) orally for two years.

DRUG

Chemotherapy

Vinorelbine 25 mg/m\^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles, cisplatin 75 mg/m\^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m\^2, day 1)/cisplatin (75 mg/m\^2, day 1) for 4 cycles.

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Caicun Zhou, MD · Shanghai Pulmonary Hospital, Shanghai, China

  • Jianxing He, MD · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-08
Primary Completion
2022-06-30
Completion
2023-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT02448797 on ClinicalTrials.gov