Adjuvant Chemotherapy With or Without Intercalated Icotinib

Nanfang Hospital, Southern Medical University

Status: Not yet enrolling

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Other: chemotherapy; Drug: Placebo; Drug: Icotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03983811

NFEC-2019-077

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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174 participants in 2 patient groups, including a placebo group

Chemotherapy+Icotinib

Experimental group

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

Treatment:

Other: chemotherapy

Drug: Icotinib

Chemotherapy+Placebo

Placebo Comparator group

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

Treatment:

Other: chemotherapy

Drug: Placebo