Phase 3
Completed N=174
Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR
Source: ClinicalTrials.gov NCT00446225 ↗Enrolled (actual)
174
Serious AEs
30.1%
Results posted
Mar 2025
Primary outcomePrimary: Progression Free-survival — 9.4; 5.2 months — p=0.0001
◆ Published Evidence
Highly cited
5,533citations · ~395 / year
Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial.
Summary
A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.
Linked Publications (4)
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Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial.
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Association of EGFR L858R Mutation in Circulating Free DNA With Survival in the EURTAC Trial.
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The impact of EGFR T790M mutations and BIM mRNA expression on outcome in patients with EGFR-mutant NSCLC treated with erlotinib or chemotherapy in the randomized phase III EURTAC trial.
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ROR1 as a novel therapeutic target for EGFR-mutant non-small-cell lung cancer patients with the EGFR T790M mutation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free-survival |
9.4; 5.2 | 0.0001 sig |
| SECONDARY Objective Response |
2.3; 0; 62.8; 16.1; 18.6; 49.4 | — |
| SECONDARY Overall Survival |
33.4; 29.9 | 0.043 sig |
| SECONDARY Molecular Markers Related to EGFR and Study Pathology |
30; 29; 24; 23; 32; 35 | — |
Eligibility Criteria
Inclusion criteria
- Informed consent
- Histologically confirmed diagnosis of NSCLC, non epidermoid, stage IV or IIIB with pleural effusion, or N3 tumours not candidate for thoracic radiotherapy, harbouring deletions in the exon 19 or mutation in the exon 21 in the TK of the EGFR.
- Either measurable or evaluable disease.
- Age > 18 years.
- ECOG performance status 2, according to the NCI-CTC criteria.
- Evidence of spinal cord compression.
- Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding.
- Any other severe disease or clinical conditions, as, but not only:
- Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
- History of significant neurological or psychiatric disorders, including dementia and epileptic seizures.
- Uncontrolled active infection.
- Uncontrolled peptic ulcer.
- Unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
- AST and/or ALT > 1.5 x UNL associated to alkaline phosphatase > 2.5 x UNL.
- Any other underlying severe process affecting the ability to take part in the study.
- Absolute contraindication for steroids.
- Dementia or significant mental disorder interfering the understanding and giving the informed consent.
- History of other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, radically treated prostatic carcinoma with good prognostic (Gleason = 6). History of other curatively treated malignancy and no evidence of disease within the past 5 years.
Data sourced from ClinicalTrials.gov (NCT00446225) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.