Clinical trial · Interventional
Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations
NCT01312337CI-TRIAL-00004548unknownPhase 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 investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.
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 |
|---|---|---|---|
| Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| salvage iressa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Iressa for EGFR wild group
- description
- salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients
- interventionNames
- Drug: salvage iressa
Primary outcomes (1)
- measure
- To determine disease control rate at 8 weeks will be 35% or higher in the the study group
- timeFrame
- 6 months after the enrollment of the last patients
Secondary outcomes (1)
- measure
- The number of patients who live longer than 6 months after enrollment
- timeFrame
- 6 months after the enrollment of the last patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven NSCLC * Ineligibile for curative treatment (namely, stage IIIb or IV) * History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21) * At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1) * 18 years old or older * Performance status ECOG 0-2 * Adequate organ function as evidenced by the following: * Absolute neutrophil count \> 1.0 x 109/L * Platelets \> 75 x 109/L * Total bilirubin ≤ 1.5 UNL * AST and/or ALT \< 5 UNL * Creatinine clearance ≥ 45mL/min Exclusion Criteria: * Previous EGFR TKI therapy history * Systemic anticancer therapy within the previous 3 weeks * Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer * Other concurrent illness that would preclude study participation (severe heart disease) * Other concurrent physical condition (e.g., infectious disease) that would preclude study participation * Pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.