A Phase 2, Open-label Study of IMC-1121B in Combination with Paclitaxel and Carboplatin as First-line Therapy in Patients with Stage IIIB/IV Non-small Cell Lung Cancer
- Conditions
- Stage IIIB/IV Non-small Cell Lung CancerMedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIBMedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV
- Registration Number
- EUCTR2007-006715-22-GB
- Lead Sponsor
- ImClone LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 (< 3 cm from the carina) identified by computed tomography scan (CT) or chest X-ray, the patient must undergo a magnetic resonance imaging (MRI) of the chest or intravenous contrast CT scan within 4 weeks of anticipated study entry, to exclude major airway or blood vessel invasion (in the investigator’s opinion) by cancer.
2. The patient has advanced NSCLC (Stage IIIB not suitable for radiation therapy or
chemoradiotherapy at study entry, or Stage IV). Patients with an earlier stage of disease that has relapsed with a higher stage are eligible provided chemotherapy or radiation therapy for pre-relapsed disease was completed > 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 < 1+ (ie, either 0 or trace) obtained within 2 weeks prior to the first dose of study medication. If urine dipstick is = 1+, a 24-hour urine for protein must demonstrate < 500 mg of protein in 24 hours to allow participation in the study.
9. The patient has adequate coagulation function, as defined by international normalized ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 5 seconds above ULN if not receiving anticoagulation therapy. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, and if on warfarin must have therapeutic INR and have no active bleeding (defined as within 14 days of first dose of study medication) or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
10. The patient agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study medication.
11. The patient has provided 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
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 < 1 year prior to the first dose of study medication.
6. The patient has any concurrent malignancy other than basal cell skin cancer, or
carcinoma in situ of the cervix. Patients with adequately treated cancers of other
histologies who have been disease-free for more than 3 years prior to the first dose of study medication are eligible.
7. The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy.
8. The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
9. The patient has uncontrolled thrombotic or hemorrhagic disorders.
10. The patient has poorly-controlled hypertension (ie, blood pressure in abnormal range despite medical management).
11. The patient is receiving chronic daily treatment with aspirin (> 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method