Clinical trial · Interventional
A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer
NCT01066884CI-TRIAL-00023626completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib [Tarceva] | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: erlotinib [Tarceva]
Primary outcomes (1)
- measure
- Incidence of adverse events (AEs)
- timeFrame
- Length of patient on study (length of time of patient on study determined by investigator)
Secondary outcomes (3)
- measure
- Best Response Rate per investigator assessment
- timeFrame
- Length of patient on study (length of time of patient on study determined by investigator)
- measure
- Time to Progression (TTP)
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients \>= 18 years of age; * inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer; * ECOG performance status of 0-3; * previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy. Exclusion Criteria: * prior systemic anti-tumor therapy with HER1/EGFR inhibitors; * unstable systemic disease; * any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer; * any significant ophthalmologic abnormality.
References
Publications (0)
Data not yet available
No reference posted for this study.