Clinical Trials /

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

NCT02448797

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02448797

Trial Eligibility

Document

Title

  • Brief Title: Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation
  • Official Title: Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA Non-small Cell Lung Cancer With EGFR-mutation: a Randomized, Positive-controlled, Phase 3 Study (EVIDENCE, CCTC-1501)

Clinical Trial IDs

  • ORG STUDY ID: BD-IC-IV-61
  • SECONDARY ID: CCTC-1501
  • NCT ID: NCT02448797

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
IcotinibConmanaicotinib
ChemotherapyNavelbine, ALIMTAstandard chemotherapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
icotinibExperimental125 mg three times daily (375 mg per day) orally for two years.
  • Icotinib
standard chemotherapyActive ComparatorVinorelbine 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.
  • Chemotherapy

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically confirmed non-small cell lung cancer after surgical resection

          -  Stage II-IIIA disease according to 7th edition of TNM staging

          -  Positive EGFR gene mutation (19/21)

          -  ECOG 0-1

          -  At least 1-year life expectancy

          -  Adequate organ function

        Exclusion Criteria:

          -  Previous systemic anti-tumor therapy, including chemotherapy or targeted
             therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine
             kinase inhibitor, etc

          -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with
             the exception of basal cell carcinoma or cervical cancer in situ

          -  Pneumonectomy of right lung

          -  Any unresolved chronic toxicity from previous anticancer therapy

          -  Allergic to study drug
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:disease free survival
Time Frame:48 months
Safety Issue:
Description:the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death

Secondary Outcome Measures

Measure:overall survival
Time Frame:60 months
Safety Issue:
Description:The time from the date of randomization to death from any cause

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Betta Pharmaceuticals Co., Ltd.

Last Updated

July 20, 2021