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Dalotuzumab + Erlotinib in Recurrent NSCLC
NCT00654420Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2008
- Primary completion
- Nov 2009
- Sponsor
- Merck & Co.
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- dalotuzumab
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, randomised, open-label trial of dalotuzumab in non-small cell lung cancer (NSCLC) (4 arms), sponsored by Merck & Co. Primary endpoints: Dose-Limiting Toxicity at 4 weeks and Progression-Free Survival up to 20 months. Started Mar 2008; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
Ph I: Dalotuzumab 5 mg/kg + Erlotinib
Dalotuzumab 5 mg/kg IV weekly + Erlotinib 150 mg PO daily
Ph I: Dalotuzumab 10 mg/kg + Erlotinib
Dalotuzumab 10 mg/kg IV weekly + Erlotinib 150 mg PO daily
Ph II: Dalotuzumab 10 mg/kg + Erlotinib
Dalotuzumab 10 mg/kg IV weekly + Erlotinib 150 mg PO daily
Ph II: Erlotinib
Erlotinib 150 mg PO daily
03
Who it enrols
Adult patients with locally advanced or metastatic NSCLC who have relapsed after at least one prior chemotherapy regimen. Patients must not have received prior EGFR or IGF1R targeted therapies.
04
Endpoints
Primary
Dose-Limiting Toxicity
Progression-Free Survival
Secondary
Overall Survival
Objective Response Rate
05
Results
Not all primary endpoints met
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