Status:
UNKNOWN
Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Collaborating Sponsors:
China-Japan Friendship Hospital
Peking University Cancer Hospital & Institute
Conditions:
Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Detailed Description
Cisplatin-based adjuvant chemotherapy is standard of care for patients with stage II-IIIA non-small cell lung cancer (NSCLC). Activating somatic mutations of the tyrosine kinase domain of epidermal gr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03381430
Start Date
June 1 2018
End Date
December 1 2025
Last Update
December 22 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
China-Japan Friendship Hospital
Beijing, China