Trials / Completed
CompletedNCT02264210
Icotinib for Completed Resected IB NSCLC With EGFR Mutation
A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.
Detailed description
Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR mutation.
Conditions
- Lung Neoplasms
- Squamous Cell Lung Cancer
- Adenocarcinoma of the Lung
- Adenosquamous Cell Lung Cancer
- Large Cell Lung Cancer
- Bronchial Neoplasms
- Stage IB Non-small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Icotinib | Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months. |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2020-12-01
- Completion
- 2022-07-01
- First posted
- 2014-10-15
- Last updated
- 2024-09-25
- Results posted
- 2024-09-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02264210. Inclusion in this directory is not an endorsement.