Clinical trial · Interventional
Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV
ERLOTINIB, A TYROSINE KINASE INHIBITOR OF EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) AS FIRST LINE TREATMENT, IN PATIENTS WITH LOCALLY ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER (NSCLC). A PHASE II STUDY
- 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)
To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated with the presence of EGFR mutations in exons 18, 19 and 21, in this population
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 Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Tarceva
- interventionNames
- Drug: Erlotinib
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes (4)
- measure
- Overall Survival
- timeFrame
- 1-year OS
- measure
- Time to Tumor Progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC * No previous therapy for advanced/metastatic NSCLC is allowed * age \>18 years * bidimensionally measurable disease * non-smokers (or ex-smokers with less than 5 pack-years smoking history) * adenocarcinoma histology * performance status (WHO) 0-3 * adequate liver (serum bilirubin \<1.5 times the upper normal limit (UNL); AST and ALT \<2.5 times the UNL in the absence of demonstrable liver metastases, or \<5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine \<1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function * previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields * patient able to take oral medication * tissue sample for tumour mutational analysis is required Exclusion Criteria: * serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation * active infection * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * malnutrition (loss of ≥ 20% of the original body weight) * performance status: 4 * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women
References
Publications (0)
Data not yet available