Stage IIIB/IV Non-small Cell Lung Cancer MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB MedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV
Conditions
Interventions
Product Name: IMC-1121B
Product Code: IMC-1121B
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ramucirumab
CAS Number:
Sponsors
ImClone LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has histologically or cytologically confirmed NSCLC. Mixed NSCLC tumors will be categorized by the predominant cell type. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy. For squamous histology or for centrally located mediastinal masses ( 1 year prior to study entry. 3. The patient has measurable disease (as defined by Response Evaluation Criteria in Solid Tumors [RECIST], see Section 11 of protocol). 4. The patient’s ECOG performance status is = 1. 5. The patient’s age at the time of study entry is = 18 years. 6. The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) = 1500/µL, hemoglobin = 9 g/dL, and a platelet count = 100,000/µL obtained within 2 weeks prior to the first dose of study medication. 7. The patient has adequate hepatic function as defined by a total bilirubin = 1.5 mg/dL (except for known Gilbert’s disease) and transaminases and alkaline phosphatase = 5 x the upper limit of normal (ULN) obtained within 2 weeks prior to the first dose of study medication. 8. The patient has adequate renal function as defined by serum creatinine = 1.5 x ULN or calculated creatinine clearance (CrCl) > 60 mL/minute, and urine dipstick for protein =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The patient has untreated central nervous system (CNS) metastases. Patients with treated brain metastases are eligible if they have no evidence of Grade = 1 CNS hemorrhage based on pretreatment MRI or intravenous contrast CT scan (performed within 28 days prior to the first dose of IMC-1121B), are clinically stable with regard to neurologic function, and are off all steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, stereotactic radiosurgery) ending at least 2 weeks prior to the first dose of IMC-1121B, or after surgical resection performed at least 4 weeks prior the first dose of IMC 1121B. 2. The patient received prior bevacizumab therapy. 3. The patient has radiologically documented evidence of major blood vessel invasion or encasement by cancer. 4. The patient received prior systemic chemotherapy for Stage IIIB/IV NSCLC. 5. The patient received prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC 325 mg/day) or other known inhibitors of platelet function. 12. Patients with a history of gross hemoptysis (defined as bright red blood or = 1/2 teaspoon) within 2 months of entry into this trial. 13. The patient has had a serious non-healing wound, ulcer, or bone fracture within 28 days prior to first dose of study medication. 14. The patient has undergone major surgery with 28 days prior the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to the first dose of study medication. Furthermore, any patients with post-operative bleeding complications or wound complications from surgical procedures performed in the last 2 months will be excluded. 15. The patient has an elective or a planned major surgery to be performed during the course of the trial. 16. The patient has peripheral neuropathy = Grade 2 (National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0]). 17. The patient, if female, is pregnant or lactating. 18. Regardless of tumor histology, the patient has radiographic evidence of intratumor cavitation. 19. The patient has experienc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the progression-free survival (PFS) rate at 6 months of IMC-1121B administered in combination with paclitaxel and carboplatin as first-line therapy for Stage IIIB/IV non-small cell lung cancer (NSCLC).; Secondary Objective: · Evaluate the safety profile of IMC-1121B in combination with paclitaxel and carboplatin · Determine the objective response rate (ORR) · Determine the duration of response · Determine the overall survival (OS) rate at 1-year · Determine the progression-free survival · Determine the overall survival · Assess the pharmacokinetic profile and immunogenicity of IMC-1121B ;Primary end point(s): The PFS rate at 6 months is the proportion of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression as defined by RECIST, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Frequency and percentage will be used to summarize the PFS rate at 6 months along with a 95% CI to be calculated for the ITT population. | — |
Countries
United Kingdom
Outcome results
None listed