Phase Ia Trial Design

Uses

Risks & contraindications

Other

Other

Highlighted claims

• The study is a single-centre, single-arm, prospective, investigator-initiated phase Ia trial sponsored by Shanghai Chest Hospital. — Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial
• The trial evaluates intrathecal pemetrexed with or without intrathecal bevacizumab in advanced NSCLC patients with confirmed leptomeningeal metastases. — Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial
• The primary endpoint is safety, and the secondary endpoint is overall survival. — Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial
• Cohort B begins only after Cohort A completes one observation cycle with fewer than two dose-limiting toxicities. — Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial
• The trial has two predefined cohorts, with Cohort A evaluating intrathecal pemetrexed monotherapy before Cohort B evaluates combination therapy. — Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial
• The single-centre, single-arm design limits generalisability and introduces potential bias. — Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial