Clinical trial · Interventional
Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
Phase I/II Study of Induction Gefitinib and Concurrent Radiotherapy in Patients With Previously Untreated, Medically Inoperable Stage I or II 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
Why stopped (as posted): Study never moved forward with accrual.
Summary
Brief summary (as posted)
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given together with gefitinib and to see how well they work in treating patients with inoperable stage I or stage II 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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| enzyme inhibitor therapy | Procedure | — | UNRESOLVED |
| gefitinib | Drug | Gefitinib | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| protein tyrosine kinase inhibitor therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Procedure | — | UNRESOLVED |
| radiosensitization | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Any non-small cell histology allowed * T1-3, N0\* disease * No metastatic disease * Refused or ineligible for surgery * Measurable disease, defined as lesion diameter ≤ 5 cm NOTE: \*No evidence of N1 or N2 disease by positron emission tomography (PET) scan or any histological means (mediastinoscopy, thoracotomy, transbronchial, tracheal aspirations, or transesophageal aspiration by endoscopic ultrasound guidance PATIENT CHARACTERISTICS: Performance status * Any performance status Life expectancy * At least 1 year Hematopoietic * No restrictions Hepatic * No restrictions Renal * Creatinine ≤ CTC grade 2 Pulmonary * No clinically active interstitial lung disease * Chronic, stable, asymptomatic radiographic changes allowed Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception * No known severe hypersensitivity to gefitinib or any of the excipients of this product * No other malignancy within the past 5 years except basal cell cancer or carcinoma in situ of the cervix * No active or uncontrolled infection * No uncontrolled systemic disease * No psychiatric illness or other severe medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy Radiotherapy * No prior radiotherapy to the chest or mediastinum * No concurrent elective nodal irradiation Surgery * Recovered from prior surgery * No concurrent ophthalmic surgery Other * Recovered from all other prior anticancer therapy (alopecia allowed) * More than 30 days since prior nonapproved or investigational agents * No concurrent CYP3A4 inducers, including any of the following: * Phenytoin * Carbamazepine * Barbiturates * Rifampin * Phenobarbital * Hypericum perforatum (St. John's wort) * No concurrent systemic retinoids
References
Publications (0)
Data not yet available