Clinical trial · Interventional
Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status
- 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 noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination carboplatin and paclitaxel | Drug | — | UNRESOLVED |
| Tarceva (Trademark) (erlotinib HCl, OSI-774) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib
- description
- Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
- interventionNames
- Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
- type
- ACTIVE_COMPARATOR
- label
- Standard Chemotherapy
- description
- Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
- interventionNames
- Drug: Combination carboplatin and paclitaxel
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IIIB or IV Nonsmall cell lung cancer (NSCLC) * No prior chemotherapy * Eastern Cooperative Oncology Group (ECOG) Performance Status 2 * Clinically or radiologically measurable disease per RECIST criteria Exclusion Criteria: * Gastro-intestinal abnormalities * Any concurrent anticancer therapy * Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind * Other active malignancies * Uncontrolled brain metastases * Severe abnormalities of the cornea * Significant cardiac disease
References
Publications (1)
- RESULTLilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 20;26(6):863-9. doi: 10.1200/JCO.2007.13.2720. PMID 18281658