Clinical trial · Observational
An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
Efficacy and Safety of Erlotinib (Tarceva® ) Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) , Subtype Adenocarcinoma, Who Have Good Performance Status (PS 0-1) - ELEMENT
- 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 multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.
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 150 mg | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Erlotinib 150 mg
- description
- Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
- interventionNames
- Drug: Erlotinib 150 mg
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Approximately 3 years
- description
- PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.
Secondary outcomes (2)
- measure
- Percentage of Participants With Overall Response
- timeFrame
- Approximately 3 years
- description
- Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult participants, \>/= 18 years of age * Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate hematologic, renal and liver function * Participant initiating treatment with Tarceva according to the Summary of Product Characteristics Exclusion Criteria: * Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label * Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin * Previous systemic anti-cancer treatment with HER1/EGFR inhibitor
References
Publications (0)
Data not yet available