Phase III, Multicenter, Open-label, Randomized Study of Erlotinib (Tarceva®) Treatment Versus Chemotherapy in Patients with Advanced Non-small-cell Carcinoma of the Lung Who Present Mutations in the Tyrosine Kinase (TK) Domain of Epidermal Growth Factor Receptor (EGFR)

Grupo Espagnol de Cancer de Pulmon0 sites146 target enrollmentMarch 25, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: on-squamous-cell, non-small-cell lung cancer in stage IIIB and IV
Sponsor: Grupo Espagnol de Cancer de Pulmon
Enrollment: 146
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

March 25, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Grupo Espagnol de Cancer de Pulmon

•1\. Before beginning the specific procedures of the protocol, informed consent must be obtained
•in writing from the patient and documented before witnesses.
•2\. Histologic diagnosis of non\-squamous\-cell, non\-small\-cell lung cancer (NSCLC), stage IV or
•stage IIIB with malignant pleural effusion or N3 tumors not candidates for thoracic irradiation
•who present exon 19 deletions or exon 21 mutation in the tyrosine kinase domain of EGFR
•3\. Measurable or evaluable disease
•4\. Patients over 18 years
•5\. Performance status \<\= 2 on the ECOG scale
•6\. Adequate bone marrow reserve
•b. Absolute neutrophil count \> 1500/µL

•1\. Women who are pregnant or in the period of lactation.
•2\. Women of childbearing age who present a positive pregnancy test result in the baseline evaluation or who have not undergone this test.
•3\. Sexually active men and women (of childbearing age) who are not willing to use
•contraceptive methods during the study.
•4\. Previous treatment with chemotherapy for metastatic disease. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized ³ 6 months before entering the study.
•5\. Previous treatment with therapeutic agents targeting EGFR. Patients can have received radiotherapy as long as the irradiated lesion is not the only target lesion for evaluating response and as long as radiotherapy has been completed before initiating the study treatment (a 2\-week period is recommended).
•6\. Treatment with an investigational drug agent during the 3 weeks before enrollment in the study.
•7\. Any known significant ophthalmologic anomaly of the ocular surface. The use of contact lenses is not recommended.
•8\. Pre\-existent motor or sensorial neurotoxicity grade ³ 2 according to the NCI\-CTCAE scale.
•9\. Evidence of spinal cord compression.