Metastic Non-Small Cell Lung Cancer MedDRA version: 9.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic MedDRA version: 9.1 Level: LLT Classification code 10029515 Term: Non-small cell lung cancer recurrent MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB MedDRA version: 9.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV
Conditions
Interventions
Product Name: CP-751,871
Pharmaceutical Form: Solution for infusion
Current Sponsor code: CP-751,871
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2
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 histological classification of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Lung tumor with a primary diagnosis of small cell, large cells, carcinoid, sarcomatoid, salivary gland or unspecified (Unknown, Not Otherwise Specified - NOS) are excluded; 2. Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease; 3. At least 3 weeks since major surgery prior to randomization and with resolution of all acute toxicities to CTC Grade =1 (NCI CTCAE v3.0) or deemed irreversible by investigator (minor surgery such as drainage for Pleural Effusion may require shorter recovery time and don’t prevent patient entry into the study); 4. At least 2 weeks since the completion of radiation therapy prior to randomization and with resolution of all acute toxicities to CTC Grade =1 (NCI CTCAE v3.0) or deemed irreversible by investigator; 5. Males or females aged =18 years; 6. ECOG performance status (PS) 0 or 1; 7. Adequate organ function as determined by the following criteria. These must be determined within 7 days prior to enrollment. Strict adherence to these criteria is required; exceptions will not be made; a. Absolute neutrophil count (ANC) =1.5 x 10^9/L; b. Platelet count =75 x 10^9/L; c. Haemoglobin =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]) =2.5 x ULN, or =5 x ULN if liver abnormalities are due to underlying malignancy; f. Total bilirubin =1.5 x ULN. 8. Female patients must 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 (or longer if required by local regulation). All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within the 72 hours prior to starting treatment. Male patients with partners of childbearing potential must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 5 months thereafter (or longer if required by local regulation). The definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate. 9. Written, voluntary, signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial before enrollment must be provided. 10. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures, including completion of patient-reported outcome (PRO) measures. 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
Exclusion criteria: 1. No prior systemic treatment for NSCLC, except for adjuvant/neo-adjuvant chemotherapy. Adjuvant/neoadjuvant chemotherapy must have been completed =12 months prior to randomization. 2. Patients with symptomatic central nervous system (CNS) metastases are not permitted. a. Patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation at baseline to rule out metastases; b. Patients with known, asymptomatic CNS lesions are permitted; c. Patients with stable, treated brain metastasis (eg, whole brain radiation therapy or similar) are permitted (provided they are not on corticosteroids therapy). 3. 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 but is not limited to: a. Uncontrolled hypertension, uncontrolled diabetes (defined as a Hgb A1C level >8%), unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 12 months or serious uncontrolled cardiac arrhythmia; b. Uncontrolled superior vena cava syndrome; c. Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HBC) and human immunodeficiency virus (HIV). Serological testing will not be required at baseline for patients who have no symptoms suggestive of infection but is required for patients who do; d. Pre-existing peripheral neuropathy > CTCAE Grade 2; e. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol. 4. No use of any concomitant medication that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results. This includes but is not limited to: 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 pre-medication, will be allowed at the discretion of the investigator; b. Previous or concurrent therapy with any IGF-IR inhibitor. Requirement for use of growth hormone agonist or antagonist, or use of aminoglycoside (which could potentiate cisplatin nephrotoxicity); 5. Patients may not have known or suspected hypersensitivity to any of the study drugs (gemcitabine, cisplatin, or CP-751,871), study drug classes (platinum, nucleoside analogues) or excipients in the formulation of study drugs. 6. Patients must not have been admitted to an institution by virtue of an order issued by either the judicial or administrative authorities. 7. Enrollment in another concurrent therapeutic clinical trial is not permitted. 8. No other active invasive malignancies (previous malignancies are allowed if occurred =3 years prior to randomization or current in situ malignancies like in situ carcinoma of the cervix of the uterus or basal or squamous cell carcinoma of the skin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To determine whether addition of CP-751,871 prolongs the survival of NSCLC patients treated with gemcitabine and cisplatin.;Secondary Objective: Assess progression free survival in each arm; • Assess the overall response rate in each arm; • Evaluate the safety and tolerability of CP-751,871 in combination with gemcitabine and cisplatin; • Assess health-related quality of life outcomes (HRQoL) and health status in both treatment arms; • Collect pharmacokinetic data of CP-751,871 for population pharmacokinetic meta-analysis; • Monitor for the occurrence of anti-drug antibody (ADA) response to CP-751,871 treatment; • Biomarker analysis of the IGF-IR pathway in blood and tumor (upon patient consent) samples.;Primary end point(s): Overall survival defined as the time period from randomization to death due to any cause. | — |
Countries
Belgium, Czech Republic, Ireland, United Kingdom
Outcome results
None listed