Clinical trial · Interventional
Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer
A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer
NCT00266877CI-TRIAL-00032505completedPhase 2Results postedClinicalTrials.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 learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HKI-272 | Drug | Neratinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Prior Tarceva or Iressa With EGFR Mutation
- description
- HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening
- interventionNames
- Drug: HKI-272
- type
- EXPERIMENTAL
- label
- Prior Tarceva or Iressa w/o EGFR Mutation
- description
- HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening
- interventionNames
- Drug: HKI-272
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. For Arm C, less than or equal to 20 pack-years smoking history and current non smoker. A pack year = number of packs of cigarettes smoked per day x years smoked. * Progression following at least 12 weeks of treatment with Tarceva or Iressa. (Arms A and B only) * ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 (not declining within past 2 weeks). * Tumor sample available and adequate for analysis. * At least one measurable target lesion. * Adequate cardiac, kidney, and liver function * Adequate blood counts Exclusion Criteria: * More than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease. * Significant cardiac disease or dysfunction. * Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2. * Active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth. * Use of Tarceva or Iressa within 14 days of treatment day 1 (Arms A and B only). * Major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer therapy within 3 weeks of treatment day 1. * Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom. * Inability or unwillingness to swallow HKI-272 capsules. * Pregnant or breastfeeding women.
References
Publications (0)
Data not yet available
No reference posted for this study.