Adjuvant Chemotherapy With or Without Intercalated Icotinib

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients With or Without Intercalated Icotinib Therapy: a Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03983811
• Other study ID #: NFEC-2019-077
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients undergoing completely resection of EGRF mutation-positive NSCLC Staging IIB to ?A, 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• 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
• 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

Other:
• chemotherapy
Patients in each groups need to receive 4 cycles of platinum-based doublet chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	The amount of time that patient lives without known recurrence	From the date of surgery until the date of first confirmed disease relapse or metastasis, whichever came first, assessed up to 5 years
Secondary	Number of Participants with Adverse Effects		Duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years