Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation

Phase 3

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Chemotherapy; Drug: Icotinib

• Registration Number: NCT02448797
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-15
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-19
• Study Start: 2015-06-08
• Status Verified: 2020-10
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-20
• Primary Completion: 2022-06-30
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Pathologically confirmed non-small cell lung cancer after surgical resection
• Stage II-IIIA disease according to 7th edition of TNM staging
• Positive EGFR gene mutation (19/21)
• ECOG 0-1
• At least 1-year life expectancy
• Adequate organ function

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Exclusion Criteria

• Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Pneumonectomy of right lung
• Any unresolved chronic toxicity from previous anticancer therapy
• Allergic to study drug

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard chemotherapy	Chemotherapy	Vinorelbine 25 mg/m\^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles. cisplatin 75 mg/m\^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m\^2, day 1)/cisplatin (75 mg/m\^2, day 1) for 4 cycles.
icotinib	Icotinib	125 mg three times daily (375 mg per day) orally for two years.

Primary Outcome Measures

Name	Time	Method
disease free survival	48 months	the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death

Secondary Outcome Measures

Name	Time	Method
overall survival	60 months	The time from the date of randomization to death from any cause

Trial Locations

Locations (8)

307 Hospital of PLA; 🇨🇳 Beijing, Beijing, China

Fujian Provincal Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital Of Guangzhou Medical Collage; 🇨🇳 Guangzhou, Guangdong, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Medical School of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China