Clinical trial · Observational
ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations
Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.
- 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 observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.
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 (1)
- measure
- Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics
- timeFrame
- 3 years
Secondary outcomes (7)
- measure
- Objective response rate, tumor assessments according to RECIST v1.1 criteria
- timeFrame
- 3 years
- measure
- One-year overall survival (from initiation of treatment to 12 months after disease progression)
- timeFrame
- 3 years
- measure
- Time to progression
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 (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria * EGFR mutation-positive disease according to local laboratory testing * Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice Exclusion Criteria: * Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized \>6 months prior to receiving Tarceva * Participation in another clinical study * Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment
References
Publications (0)
Data not yet available