Clinical trial · Interventional
Phase II Iressa + Irradiation Followed by Chemo in NSCLC
A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer
NCT00333294CI-TRIAL-00001036completedPhase 2ClinicalTrials.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)
The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
| Radiation therapy | Procedure | — | UNRESOLVED |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To estimate the objective response rate in patients treated with this drug
Secondary outcomes (1)
- measure
- Determine the safety and toxicity of this drug in these patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent. * 18 to 75 years inclusive. * At least one measurable lesions histologically confirmed inoperable stage III NSCLC. * WHO performance status of 0 to 2 inclusive. * Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %. * Life expectancy of at least 6 months. * Using secure contraceptives precautions. Exclusion Criteria: * Any previous anti cancer therapy for NSCLC. * Known severe hypersensitivity to these products * Any evidence of clinically active interstitial lung disease * Other co-existing malignancies, symptomatic metastases. * Abnormal blood test * Weight loss of over 15% in the 3 months before the start of the study. * Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.