Clinical trial · Interventional
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
- 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 the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.
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-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| erlotinib [Tarceva] | Drug | Erlotinib | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tarceva + gemcitabine/platinum
- interventionNames
- Drug: erlotinib [Tarceva]
- Drug: gemcitabine
- Drug: cisplatin
- Drug: carboplatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo + gemcitabine/platinum
- interventionNames
- Drug: placebo
- Drug: gemcitabine
- Drug: cisplatin
- Drug: carboplatin
Primary outcomes (1)
- measure
- Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- Week 8
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>=18 years of age; * histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer; * measurable disease; * no previous chemotherapy for non-small cell lung cancer. Exclusion Criteria: * unstable systemic disease; * any other malignancies in the last 5 years.
References
Publications (0)
Data not yet available