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

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)

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02448797

Acronym

EVIDENCE

Enrollment

320

Registered

2015-05-19

Start date

2015-06-08

Completion date

2023-12-31

Last updated

2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief 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.

Interventions

DRUGChemotherapy

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.

DRUGIcotinib

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
overall survival	60 months	The time from the date of randomization to death from any cause

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026