Lung Cancer Clinical Trial
Official title:
A Phase 1/2 Study of Apatinib in Combination With AP(Pemetrexed/Cisplatin) or AC(Pemetrexed/Carboplatin) as First-line Chemotherapy for Advanced Epidermal Growth Factor Receptor(EGFR) Wild Type Non-squamous Non-small Cell Lung Cancer
The purpose of this study is to evaluate the safety and clinical activity of Apatinib in combination with AP(Pemetrexed/Carboplatin) or AC(Pemetrexed/Carboplatin) as first-line chemotherapy in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer(NSCLC).
Apatinib, an oral highly potent tyrosine-kinase inhibitor targeting VEGFR-2, has demonstrated
improved survival in previously treated patients with advanced non-small-cell lung
cancer(NSCLC).
The phase I study is conducted to explore the safety, tolerability, dose-limiting
toxicities(DLT), Maximum Tolerable Dose(MTD), and preliminary anti-tumor activity of Apatinib
combined with platinum-based doublet chemotherapy(PB-DC) in first-line advanced EGFR wild
type non-squamous non-small cell lung cancer. This will use a dose reduction trial design. A
cohort of 3~6 subjects will be enrolled at each dose level, If 0 of 3 or ≤ 1 of 6 subjects
experience a DLT, the phase I trial will stop and the current dose will be considered the
MTD. If 1 of 6 or more subjects experiences a DLT, dose reduce to the next dose will occur.
Following completion of the dose de-escalation trial and determination of MTD, A randomized
controlled trial(RCT) including 30 subjects may be enrolled to further evaluate safety,
tolerability, and preliminary anti-tumor activity of Apatinib in combination with
platinum‐based doublet chemotherapy(PB-DC) in the same target population.
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