Chemotherapy of NSCLC With or Without Icotinib

NCT02430974 | Unknown Phase 2

• 1 other identifier: NFYYXWK-CKC1102
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to IIIA EGFR-mutated NSCLC.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years

Secondary Outcomes (1)

• Number of Participants with Adverse Effects

  duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years

Study Arms (2)

Chemotherapy

NO INTERVENTION

patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).

Chemotherapy & Icotinib

EXPERIMENTAL

patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).Two weeks after chemotherapy completed, patients assigned to the consolidation therapy group began oral icotinib treatment (125 mg, thrice daily). Icotinib treatment continued for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity.

Drug: Icotinib

Interventions

Icotinib DRUG

Patients in experimental group will receive oral Icotinib for 4-8months.

Chemotherapy & Icotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing completely resection of EGRF mutation-positive NSCLC
• Staging ⅠB (with high risk factor) to ⅢA
• PS = 0 or 1
• Adequate hematological, biochemical and organ functions

You may not qualify if:

• Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Related Publications (1)

• Feng S, Wang Y, Cai K, Wu H, Xiong G, Wang H, Zhang Z. Randomized Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients with or without Icotinib Consolidation Therapy. PLoS One. 2015 Oct 16;10(10):e0140794. doi: 10.1371/journal.pone.0140794. eCollection 2015.

  PMID: 26474174 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kaican Cai, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2015
• First Posted: April 30, 2015
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2018
• Last Updated: April 30, 2015

Record last verified: 2015-04