Clinical trial · Interventional
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer
- 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)
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (5)
- measure
- Complete resection rate
- measure
- Overall survival rate
- measure
- Median disease-free survival
- measure
- Complete pathological response rate
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer * pN2 disease proven by mediastinoscopy * Meets any of the following criteria: * Never smoked * EGFR mutations (in exon 18, 19, or 21)\* * FISH positive for EGFR\* NOTE: \*Irrespective of smoking history * Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan, according to RECIST * Feasible to undergo pneumonectomy or lobectomy PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-1 * FEV\_1 ≥ 2.0 L in preoperative pulmonary function test * Hemoglobin ≥ 9.0 g/dL * WBC 4,000-12,000/μL * ANC ≥ 1,500/μL * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3.0 times ULN * AST and ALT ≤ 3.0 times ULN * Creatinine ≤ 1.5 times ULN * Negative pregnancy test Exclusion criteria: * Severe complications or infections * Pregnant or breast-feeding women * Clinically significant heart disease * Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus * Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma PRIOR CONCURRENT THERAPY: * No prior radiotherapy, chemotherapy, hormone therapy, or target therapy * No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy
References
Publications (0)
Data not yet available