A combined phase 1 and 2 study investigating the combination of RAD001 and erlotinib in patients with advanced NSCLC previously treated only with chemotherapy - N/A

• Conditions: ung cancer is one of the most common malignancies in developed countries and accounts for millions of deaths worldwide. Two-thirds of NSCLC patients have advanced disease and are considered incurable by surgery or chest radiation. The current standard of care for these patients is chemotherapy. Novel therapeutic agents are under development. Epidermal growth factor inhibitors have already demonstrated a clinical benefit to patients with advanced NSCLC failing standard chemotherapy regimens.; MedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic

• Registration Number: EUCTR2004-003017-16-DK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-08
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patients with advanced NSCLC (unresectable or metastatic)
• Age = 18 years old
• Pathologic confirmation of NSCLC (must include accurate histology in phase 2 part of the study)
• Patients entered on the phase 2 part of the study must have at least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
• Previous chemotherapy treatment for advanced disease with documented tumor progression (serial CT scans demonstrating progressive disease according to RECIST must be available) despite = 2 chemotherapy schedules for treatment of advanced disease (previous therapy for localized disease is not counted), one of which must have included cisplatin or carboplatin
• More than two weeks since any major surgery, completion of radiation, or completion of all prior chemotherapy (adequately recovered from the acute toxicities of any prior therapy)
• WHO performance status = 2 in the phase 1 part of the study
• WHO performance status = 1 in the phase 2 part of the study
• Adequate bone marrow function as shown by: ANC = 1.5 x 109/L, Platelets = 100 x 109/L, Hgb > 9 g/dL
• Adequate liver function as shown by serum: bilirubin = grade 2 and transaminases activity = 3 x ULN. With the exception of serum transaminases (< 5 x ULN) if the patient has liver metastases.
• Signed informed consent
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

Exclusion Criteria

Patients will be excluded if they meet ANY of the following criteria:
• Concurrent therapy with agents otherwise used in treatment of cancer (for example, methotrexate for rheumatoid arthritis)
• Treatment with any other investigational drugs within the preceding 4 weeks
• Prior treatment with an EGFR inhibitor (either a small molecule EGFR TK inhibitor or ant-EGFR antibody)
• Chronic treatment with steroids or another immunosuppressive agent
• Leptomeningeal or uncontrolled brain metastases, including patients who continue to require glucocorticoids or intrathecal chemotherapy for brain or leptomeningeal metastases (documented by lumbar puncture)
• Malignancies other than lung cancer within the past 2 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
• Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
• A known history of HIV or previous seropositivity for the virus
• Patients with active skin, mucosa, ocular or GI disorders of grade > 1
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 or erlotinib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001 or erlotinib)
• History of noncompliance to medical regimens
• Patients unwilling to or unable to comply with the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified