Clinical trial · Interventional
Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers
- 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 will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| Tarceva | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib
- description
- 150 mg erlotinib daily
- interventionNames
- Drug: Tarceva
- type
- EXPERIMENTAL
- label
- Erlotinib + chemotherapy (intercalated)
- description
- carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
- interventionNames
- Drug: Tarceva
- Drug: carboplatin
- Drug: paclitaxel
Primary outcomes (1)
- measure
- 6-month Progression-free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 * Histologically or cytologically documented non-small cell lung cancer (NSCLC) * Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2 * Radiologically measurable or evaluable disease No prior chemotherapy * 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening * Tumor tissue block or fine needle aspirate Exclusion Criteria: * Any concurrent anticancer therapy or radiation * Other active malignancy * Uncontrolled brain metastases * GI abnormalities * Severe abnormalities of the cornea * Significant cardiac disease * Active infection
References
Publications (0)
Data not yet available