Non Small Cell Lung Cancer Clinical Trial
Official title:
MK-0646 IMPACT Study: MK-0646, Insulin Growth Factor 1 Receptor Antibody in Stage IIIB or IV Metastatic Non-Squamous Lung Cancer, Combined With Pemetrexed (Alimta) and Cisplatin, a Randomized Phase II Trial.
This study will compare the rate of chemotherapy: pemetrexed and cisplatin compared with the combination of pemetrexed/cisplatin with MK-0646. The other purposes are to determine how long we can control the cancer growth and toxicity and safety of the combination. Laboratory research with the tumor tissue and blood obtained will be done to assess IGF-1R expression and related markers and correlate with response and survival.
Insulin-like Growth factor 1 receptor (IGF-1R) is a tyrosine kinase receptor that regulates
cell growth, proliferation and apoptosis.(4) Increased IGF1 signaling results in
upregulation of proliferation and inhibition of apoptosis through RAF and PI3K pathways.(5)
Several types of cancer, including non-small cell lung cancer, express IGF-1R and its
ligand. The sequestration of IGF by IGF binding protein was associated with improved
survival in patients with resected stage I lung cancer.(6) High expression of IGF-1R is
associated with poor survival in surgically resected stage I lung cancer, specifically
adenocarcinoma subtype. Patients with adenocarcinoma and never smoker had higher expression
of IGF-1R vs. squamous cell carcinoma and smokers.(7). Low IGF-1R expression was associated
with significant improvement in survival in the adenocarcinoma lung cancer but there was a
lack of correlation between expression of IGF1R and survival in patients with squamous cell
histology.
Monoclonal antibodies target the extracellular domain of IGF-IR and small molecules inhibit
IGF-1R kinase. This is a potential new strategy in the treatment of lung cancer.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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