Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To explore the survival benefit of the gefitinib combined with radiotherapy as adjuvant therapy for completely resected patients with Pathological stage IIIA-N2 NSCLC harbouring sensitive mutations of EGFR.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.
• Collaborators: Beijing Cancer Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; China-Japan Friendship Hospital; Chinese PLA General Hospital
• Treatments: Gefitinib

Criteria

Inclusion Criteria:

• Written informed consent provided.

• Males or females aged ≥18 years, < 75 years.

• Target population is completely resected pathological stage IIIA-N2 NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation.

• Underwent radical resection

• The patient did not receive any neoadjuvant chemotherapy or EGFR-TKI targeted therapy before surgery

• Patient who can start the investigational therapy within 3-6 weeks after the complete resection

• ECOG performance status 0-1.

• Life expectancy ≥12 weeks.

• Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).

• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.

• Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.

• Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

• Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).

• Patients with prior any systemic chemotherapy, immunotherapy or biotherapy

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

• Patients with prior radiotherapy.

• Not fully recovered from the previous surgery.

• History of another malignancy in the last 5 years with the exception of the following:

basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix.

• Patients who harbouring exon 20 T790M mutation.

• Patient who has any active infection (e.g. acute pneumonia, hepatitis B or hepatitis C).

• Dysphagia or known malabsorption of drugs.

• Patient with serious heart, liver, kidney or other important organ dysfunction.

• Pregnancy or lactation women or women may be positive for pregnancy before the first medication.

• Patient has fertility but not willing to take contraceptive measures or whose sexual partners are unwilling to take contraceptive measures.

• Researcher believes the patient's condition is not suitable for the clinical study.

• Researcher judged the patient's lack of compliance with the study.

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