Clinical trial · Interventional
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
- 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)
This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression. Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib (Tarceva) | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- A
- interventionNames
- Drug: Erlotinib (Tarceva)
Primary outcomes (1)
- measure
- Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
- timeFrame
- 6 months
- description
- Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 24 months
- description
- Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Performance status 0-1. * Weight Loss \< 10% in preceding 3 months * Age 18 years and older. * Adjuvant chemotherapy allowed if \> 6 months from protocol entry * Adequate Organ Function * Liver enzymes \< 2X normal, bilirubin = normal * Oxygen saturation\> 89% on room air unless chronically oxygen dependent (not cancer related) * Creatinine \<2.0 mg Exclusion Criteria: * Not pregnant or lactating. * No Clinical Brain Metastases * No prior chemotherapy for systemic disease * Imminent need for chemotherapy for impending organ dysfunction is not allowed
References
Publications (0)
Data not yet available