Clinical trial · Interventional
Adjuvant Chemotherapy With or Without Intercalated Icotinib
Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients With or Without Intercalated Icotinib Therapy: a Randomized, Placebo-controlled Trial
- 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)
Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study aims to assess the efficacy and safety of adjuvant chemotherapy with or without Intercalated combination of icotinib in patients undergoing resection of stage IIB to IIIA (N1-2) EGFR-mutated NSCLC.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Other | — | UNRESOLVED |
| Icotinib | Drug | Icotinib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy+Icotinib
- description
- Patients receive 4 cycles of platinum-based doublet chemotherapy on day 1 with intercalated icotinib (D8-15) every 3 weeks, and continued icotinib for 2 years or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity
- interventionNames
- Drug: Icotinib
- Other: chemotherapy
- type
- PLACEBO_COMPARATOR
- label
- Chemotherapy+Placebo
- description
- Patients receive 4 cycles of platinum-based doublet chemotherapy on day 1 with intercalated placebo (D8-15) every 3 weeks, and continued placebo for 2 years or until the occurrence of disease relapse, metastasis or unacceptable toxicity
- interventionNames
- Drug: Placebo
- Other: chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing completely resection of EGRF mutation-positive NSCLC Staging IIB to ⅢA, N1-2; PS = 0 or 1; Adequate hematological, biochemical and organ functions Exclusion Criteria: * Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating
References
Publications (0)
Data not yet available