Clinical trial · Interventional
Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
NCT01929200CI-TRIAL-00018003unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1-year treatment with icotinib | Drug | — | UNRESOLVED |
| 2-year treatment with icotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1-year treatment with icotinib
- description
- Patients will receive 1-year treatment with icotinib after operation.
- interventionNames
- Drug: 1-year treatment with icotinib
- type
- EXPERIMENTAL
- label
- 2-year treatment with icotinib
- description
- Patients will receive 2-year treatment with icotinib after operation.
- interventionNames
- Drug: 2-year treatment with icotinib
Primary outcomes (1)
- measure
- Recurrence-free Survival
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The patients signed the written informed consent * The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation * The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy * The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2 Exclusion Criteria: * Patients with unresected tumor * Wild EGFR type * Allergic to the study drug * Patients have severe non-cancerous diseases * Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
References
Publications (2)
- BACKGROUNDLv C, Ma Y, Feng Q, Fang F, Bai H, Zhao B, Yan S, Wu N, Zheng Q, Li S, Chen J, Wang J, Feng Y, Wang Y, Pei Y, Fang J, Yang Y. A pilot study: sequential gemcitabine/cisplatin and icotinib as induction therapy for stage IIB to IIIA non-small-cell lung adenocarcinoma. World J Surg Oncol. 2013 Apr 26;11:96. doi: 10.1186/1477-7819-11-96. PMID 23621919
- DERIVEDLv C, Wang R, Li S, Yan S, Wang Y, Chen J, Wang L, Liu Y, Guo Z, Wang J, Pei Y, Yu L, Wu N, Lu F, Gao F, Chen J, Liu Y, Wang X, Li S, Han B, Zhang L, Ma Y, Ding L, Wang Y, Yuan X, Yang Y. Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study). ESMO Open. 2023 Aug;8(4):101565. doi: 10.1016/j.esmoop.2023.101565. Epub 2023 Jun 20. PMID 37348348