Clinical trial · Interventional
Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
A Open-label, One-arm Trial of Gefitinib Combined With Radiotherapy as Adjuvant Therapy in Completely Resected Patients With Pathological Stage IIIA-N2 Non-small Cell Lung Cancer Harbouring Sensitive Mutations of EGFR
NCT03381430CI-TRIAL-00030878unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gefitinib + Radiotherapy
- description
- Experimental: Gefitinib Gefitinib 250 mg/day oral daily Radiotherapy Total dose 50-54Gy, divided dose 1.8-2Gy
- interventionNames
- Drug: Gefitinib
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- CT scan, abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan every 12 months for up to 3 years.
- description
- From start of anti-cancer therapy until progression or death. To evaluate the disease free survival of gefitinib combined with radiotherapy as adjuvant therapy in completely resected patients with Pathological stage IIIA-pN2 NSCLC harbouring sensitive mutations of EGFR.Disease free survival (DFS)- defined as the time from initial medication to the first documented disease progression or death, whichever occurs first.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.