Clinical trial · Interventional
Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer
A Phase II Study to Evaluate the Efficacy and Safety of Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer (NSCLC)
NCT00173875CI-TRIAL-00000811completedPhase 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 purpose of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer (NSCLC)
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iressa | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Iressa
- interventionNames
- Drug: Iressa
Primary outcomes (1)
- measure
- The primary objective of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer
- timeFrame
- 2005~2007
Secondary outcomes (1)
- measure
- To evaluate 1) Individual response rate 2) Time to progression 3) Overall survival (OS) at year1 4) Progression free survival (PFS) at year1 5) Toxicity
- timeFrame
- 2005~2007
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed stage IIIB/IV NSCLC * No immediate need for palliative radiotherapy and No prior chemotherapy * age \> 20 Y/O * ECOG PS: 0 - 2 * ANC \>2000 * PLT \>100k * Hb \> 10 * total bilirubin \< 2.0 mg/dL * serum creatinine \< 2 mg/dl * SGPT and SGOT \< 2.5 ×ULN, alkaline phosphatase \< 5 ×ULN * life expectancy \>6mos. Exclusion Criteria: * If the patients have brain metastases or receive radiotherapy, the disease must be stable for more than 6 weeks after the last dose of radiotherapy * 2nd malignancies * Unable to swallow tablets * Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements * Pregnant or lactating patients * Participation in other clinical trials within 30 days of study entry * Major systemic disease which in the investigator's opinion might confound the clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.