Clinical trial · Interventional
Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
NCT02125240CI-TRIAL-00033783ICWIPunknownPhase 3ClinicalTrials.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)
The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| EGFR Positive Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib | Drug | Icotinib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Icotinib
- description
- 125 mg three times daily (375 mg per day) by mouth
- interventionNames
- Drug: Icotinib
- type
- ACTIVE_COMPARATOR
- label
- Placebo
- description
- 1 tablet three times daily by mouth
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 36 months
- description
- DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed lung adenocarcinoma after surgical resection * Stage II-IIIA disease according to 7th edition of TNM staging * Patients must harbor sensitive EGFR gene mutation (19/21) * Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy 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 * Presence of metastatic disease * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * Any unresolved chronic toxicity from previous anticancer therapy * Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)
References
Publications (1)
- DERIVEDLiu YT, Hao XZ, Liu DR, Cheng G, Zhang SC, Xiao WH, Hu Y, Liu JF, He M, Ding CM, Zhang L, Wang J, Li H, Dong GL, Zhi XY, Li J, Shi YK. Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. Cancer Manag Res. 2020 Jun 17;12:4633-4643. doi: 10.2147/CMAR.S240275. eCollection 2020. PMID 32606956