Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation

A Randomized ,Opened, Prospective Controlled Trial of Clinical Effectiveness for Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Gene Mutation

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02283424

Enrollment

Registered

2014-11-05

Start date

2014-10-31

Completion date

2017-12-31

Last updated

2014-11-05

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

Conditions

Neoplasms, Therapy-Associated

Brief summary

This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation

Detailed description

In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up

Interventions

DRUGIcotinib

compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery

DRUGchemotherapy (Carboplatin and Docetaxel)

as control group,compared with Icotinib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 18-75 years old * Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery * The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion criteria

* Mismatch conditions above * Have used other anti-cancer therapy drug before the trial and may influence the outcome

Design outcomes

Primary

Measure	Time frame
Recurrence-free Survival	6 months

Secondary

Measure	Time frame
Overall survival	6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026