Clinical trial · Interventional
Iressa v BSC (Best Supportive Care) in First Line NSCLC
A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
- 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 the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV 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 |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gefitinib
- description
- ZD1839 + BSC (best supportive care)
- interventionNames
- Drug: Gefitinib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo + BSC (best supportive care)
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- To compare Iressa v best supportive care in terms of progression free survival
- timeFrame
- Progression-free survival
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC * NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy * Not suitable for chemotherapy * WHO Performance status 2 or 3 Exclusion Criteria: * Newly diagnosed CNS mets * Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity * Other co-existing malignancies * ALT/AST greater than 5 x upper limit of normal * ANC less than 1.0 x 109/L or platelets less than 100 x 109/L
References
Publications (0)
Data not yet available