Non-small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Interventions
Product Name: MK- 0646
Pharmaceutical Form: Solution for infusion
CAS Number: N/A
Current Sponsor code: MK-0646
Other descriptive name: humanized monoclonal IgG1 antibody against insulin like growth f
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age greater than or equal to 18 years •Histologically/cytologically documented, unresectable, locally advanced, recurrent or relapsed metastatic Stage IIIB/IV NSCLC •Measurable disease •ECOG performance status 0-2 •Adequate hematologic, renal, and hepatic function: ANC greater than or equal to 1,500/µl, platelet greater than or equal to 100,000/ µl, Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Prior EGFR – TKI inhibitor/anti-EGFR mAb therapy is not allowed •Prior IGF1R - TKI inhibitor/anti-IGF1R mAb therapy is not allowed •No more than 2 prior systemic therapies •Patient who has not completed radiotherapy with complete resolution of toxicities at least 2 weeks prior to beginning this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: To determine the safety and tolerability of erlotinib in combination with MK-0646 in patients with recurrent NSCLC. Phase II: To evaluate the effect of the combination of erlotinib and MK-0646 on PFS in patients with recurrent NSCLC. ;Secondary Objective: Radiological: To quantify response rate (RR) by response criteria in solid tumors (RECIST) criteria. Clinical: To determine overall survival (OS). ;Primary end point(s): The difference in progression-free survival (PFS) between treatment groups. | — |
Countries
Austria, France, Germany, Italy, Netherlands, Sweden, United Kingdom
Outcome results
None listed