Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

• Written informed consent provided.

• Aged 18-75 years.

• Had completely resected pathological confirmed stage IIA-IIIA NSCLC.

• EGFR activating mutation in exon 19 or 21.

• Had completed four cycles of platinum-based adjuvant chemotherapy.

• Able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy.

• ECOG performance status of 0-1.

• Had a life expectancy of 12 weeks or more.

• Adequate hematological function, adequate liver function and renal function.

• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

• Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.

Exclusion Criteria:

• Had had previous chemotherapy besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).

• Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.

• Any evidence confirmed tumor recurrence before investigational therapy.

• Known severe hypersensitivity to icotinib or any of the excipients of this product.

• Evidence of clinically active interstitial lung disease.

• Eye inflammation not fully controlled or conditions predisposing the subject to this.

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

• Known human immunodeficiency virus (HIV) infection.

• Pregnancy or breast-feeding women.

• Ingredients mixed with small cell lung cancer patients.

• History of neurologic or psychiatric disorders.