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)
- Conditions
- on-squamous-cell, non-small-cell lung cancer in stage IIIB and IVMedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer
- Registration Number
- EUCTR2006-003568-73-FR
- Lead Sponsor
- Grupo Espagnol de Cancer de Pulmon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 146
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
c. Platelet count > 100,000/µL
7. Adequate kidney function: serum creatinine <= 1.5 x upper limit of normality (ULN)
8. Adequate liver function
9. Patients must be accessible for treatment and follow-up.
10. Patients capable of proper therapeutic compliance and accessible for correct follow-up.
11. Women of childbearing age must have a negative serum or urine pregnancy test within
7 days before beginning treatment.
12. Patients of both sexes of childbearing age, including women who had their last menstrual
period in the last 2 years, must use an effective contraceptive method.
13. Oral swallowing capability.
14. Patients with asymptomatic and stable cerebral metastases receiving medical treatment will be eligible for the study. Patients who have received radiation therapy for their cerebral metastases before the initiation of systemic treatment for non-small-cell lung cancer also will be eligible.
15. Absence of intestinal transit problems, such as malabsorption syndrome, chronic intestinal inflammatory disease, or other pathologies that, in the judgment of the investigator, can alter absorption of the medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
10. Incapacity to take oral medication or previous surgical procedures that affect absorption and imply the need for intravenous or parenteral feeding.
11. Other serious diseases or clinical conditions,
12. Absolute contraindication for steroid use.
13. Dementia or significantly disturbed mental state that could interfere with the patient’s understanding and granting of informed consent.
14. History of another neoplasm other than carcinoma in situ of the uterine cervix, basal cell skin carcinoma treated adequately, or prostate carcinoma with a good prognosis treated radically. History of another neoplasm treated curatively and without evidence of disease in the last 5 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare progression-free survival in the two treatment arms of the study (conventional chemotherapy vs. erlotinib) in patients with non-squamous, non-small-cell lung cancer (NSCLC) in advanced stages (stages IIIB and stage IV) who have not received previous chemotherapy for their disease and who present mutations in the tyrosine kinase domain of the epidermal growth factor receptor.;Secondary Objective: . Objective response index<br>· One-year survival<br>· Overall survival<br>· Location of progression<br>· Safety profile<br>· Molecular markers related to the EGFR signaling pathway and the pathology under study<br>· Quality of life (LCSS);Primary end point(s): Progression-free survival.
- Secondary Outcome Measures
Name Time Method