Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.

To evaluate the drug-drug interactions between anlotinib hydrochloride capsules and omeprazole magnesium enteric-coated tablets, as well as the pharmacokinetic properties and tolerability of anlotinib hydrochloride capsules alone and in combination with omeprazole magnesium enteric-coated tablets in healthy subjects under fasting/postprandial conditions, so as to provide guidance for subsequent clinical medication.

To evaluate the progression-free survival (PFS) and overall survival (OS) and other clinical benefits of TQB2450 or placebo combined with anlotinib + etoposide + carboplatin versus etoposide + carboplatin as first-line treatment for patients with small cell lung cancer, the incidence and severity of adverse events and serious adverse events, and the exploration of related immunogenicity and biomarkers.

Primary purpose: To observe the tolerance and safety of AL8326 after multiple administration in patients with advanced small cell lung cancer (including a small amount of bladder cancer, breast cancer, gastrointestinal stromal tumor, bile duct cancer or other solid tumors), the DLT and MTD of the drug in humans, the reversibility of toxicity, and the relationship between toxicity and dose. Secondary purpose: To recommend appropriate dosage and regimen for Phase II clinical trials; to preliminarily analyze the efficacy in patients with advanced small cell lung cancer (including a small amount of bladder cancer, breast cancer, gastrointestinal stromal tumor, bile duct cancer or other solid tumors).