Adjuvant Chemotherapy With or Without Intercalated Icotinib

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03983811

Collaborator

(none)

174

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Icotinib Drug: Placebo Other: chemotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemotherapy+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	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 Other: chemotherapy Patients in each groups need to receive 4 cycles of platinum-based doublet chemotherapy
Placebo Comparator: Chemotherapy+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	Drug: 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

Arm

Intervention/Treatment

Experimental: Chemotherapy+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

Drug: Icotinib

Other: chemotherapy

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

Placebo Comparator: Chemotherapy+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

Drug: Placebo

Other: chemotherapy

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

Outcome Measures

Primary Outcome Measures

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

Number of Participants with Adverse Effects [Duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kaican Cai, Professor, Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT03983811

Other Study ID Numbers:

NFEC-2019-077

First Posted:

Jun 12, 2019

Last Update Posted:

Jun 12, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jun 12, 2019