Adjuvant Chemotherapy With or Without Intercalated Icotinib

Not Applicable

Not yet recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Placebo; Drug: Icotinib; Other: chemotherapy

• Registration Number: NCT03983811
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-09
• Study First Submitted QC: 2019-06-11
• Last Update Submitted: 2019-06-11
• Study First Posted: 2019-06-12
• Last Update Posted: 2019-06-12
• Study Start: 2019-07-01
• Primary Completion: 2021-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy+Placebo	chemotherapy	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
Chemotherapy+Placebo	Placebo	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
Chemotherapy+Icotinib	chemotherapy	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
Chemotherapy+Icotinib	Icotinib	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

Primary Outcome Measures

Name	Time	Method
Disease free survival	From the date of surgery until the date of first confirmed disease relapse or metastasis, whichever came first, assessed up to 5 years	The amount of time that patient lives without known recurrence

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Effects	Duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years