Clinical trial · Interventional
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve 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 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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-Squamous Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib + Gemcitabine
- description
- Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
- interventionNames
- Drug: Erlotinib
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine
- description
- Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
- interventionNames
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>=18 years of age; * non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ; * ECOG PS 2; * adequate organ function. Exclusion Criteria: * prior chemotherapy or systemic anti-tumor therapy; * hypersensitivity to erlotinib; * any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.
References
Publications (0)
Data not yet available