Non Small Cell Lung Cancer MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
Conditions
Sponsors
Pfizer Inc 235 East 42nd Street New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma. 2. Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease 3. No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed =12 months prior to randomization 4. Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved to CTC Grade 1 (NCI CTCAE v3.0) 5. Age =18 years 6. ECOG performance status (PS) 0 or 1 7. Adequate organ function as determine by the following criteria. a. Absolute neutrophil count (ANC) =1.5 x 109/L b. Platelet count =75 x 109/L c. Hemoglobin =8 g/dl d. Serum creatinine =1.5 x upper limit of normal (ULN) e. Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) =5 x ULN, or =10 x ULN if liver abnormalities are due to underlying malignancy f. Total bilirubin =1.25 x ULN 8. Female patients may not be pregnant or nursing. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving study treatment and for at least 5 months thereafter. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within the 72 hours prior to starting treatment. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 5 months thereafter. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate 9. Written, voluntary informed consent must be provided a. Patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases b. Patients with known, asymptomatic CNS lesions are permitted 10.Patients with symptomatic central nervous system (CNS) metastases are not permitted. Patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases Patients with known, asymptomatic CNS lesions are permitted Patients with stable, treated brain metastasis (e.g. whole brain radiation therapy or similar) are permitted (off steroid medication) 11. No acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. This includes: a. Requirement for chronic treatment with therapeutic doses of systemic corticosteroids or use of high-dose corticosteroids (=100 mg of prednisone per day or >40 mg dexamethasone per day) within 1 week prior to treatment. Previous steroid treatment or low dose steroid use for the control of nausea and vomiting will be allowed. The use of corticosteroids for the prophylaxis or treatment of nausea and vomiting, or as chemotherapy premedication, will be allowed at the discretion of the investigator b. Uncontrolled hypertension, uncontrolled diabetes (defined as a Hgb A1C level >8%), unstable angina, myocardial infarction or symptomatic conges
Exclusion criteria
Exclusion criteria: Patients with a primary histology of adenocarcinoma NSCLC and those with unknown or unspecified (Not otherwise specified) NSCLC histology will be excluded Patients with symptomatic central nervous system (CNS) metastases are not permitted. Enrollment in another therapeutic clinical trial is not permitted Previous or concurrent therapy with any IGF1R inhibitor, growth hormone agonist or antagonist is not permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: Determine whether the addition of CP-751,871, an IGF-1R inhibitor, in combination with paclitaxel plus carboplatin prolongs survival in patients with non-adenocarcinoma NSCLC.;Secondary Objective: Secondary Objectives: • Assess progression free survival in each arm; • Evaluate the safety and tolerability of CP-751,871 in combination with paclitaxel and carboplatin; • Assess the overall response rate in each arm; • Assess health-related quality of life outcomes (HRQoL) and health states in both treatment arms; • Collect pharmacokinetic data of CP-751,871 for population pharmacokinetic meta-analysis; • Monitor for the occurrence of any anti-drug antibody in response to CP-751,871 treatment; • Explore the association pretreatment IGF-1 and change in IGF-1 with survival; • Collection of anonymized samples for molecular profiling;Primary end point(s): The primary endpoint is overall survival defined as the time from Randomization to the date of death due to any cause. | — |
Countries
Austria, Bulgaria, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Spain
Outcome results
None listed