Clinical trial · Observational
An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)
A Multicenter, Prospective, Observational Study to Identify Different Prognostic Factors Related to Survival in Patients With Previously Treated Advanced NSCLC With Wild-type Epidermal Growth Factor Receptor (EGFR) Gene.
- 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 prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patients for up to 2 years.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Cohort
Primary outcomes (3)
- measure
- Correlation of overall survival with baseline clinical/demographic patient characteristics
- timeFrame
- approximately 2 years
- measure
- Correlation of overall survival with baseline tumour characteristics
- timeFrame
- approximately 2 years
- measure
- Correlation of overall survival with previous treatment regimens
- timeFrame
- approximately 2 years
Secondary outcomes (4)
- measure
- Objective response rate (ORR), tumour assessments according to RECIST criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) * Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria: * squamous cell carcinoma lung cancer histology, and * current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of \>15 pack-years of smoking * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva Exclusion Criteria: * Current treatment with an investigational drug or participation in another investigational study * Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin * Clinically active interstitial lung disease * Recent myocardial infarction or unstable angina * Progressive or uncontrolled brain metastases
References
Publications (0)
Data not yet available