An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer

Launched by ONO PHARMACEUTICAL CO. LTD · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and tolerability of two new medications, ONO-4578 and ONO-4538, when used together with standard treatments (docetaxel and ramucirumab) for patients with advanced or recurring non-small cell lung cancer (NSCLC). This study is for patients who have already tried other treatments that didn't work and are looking for a second-line therapy. The goal is to see how well these new drugs can be tolerated by patients, helping doctors determine if they might be a good option for future treatments.

To be eligible for this study, patients must have stage III B, III C, or stage IV non-small cell lung cancer that cannot be treated with surgery or radiation. They should also expect to live for at least three more months and have a good performance status, meaning they are generally well enough to participate in the study. However, patients with severe health complications or multiple cancers are not eligible. Those who participate can expect regular monitoring and care as their safety and response to the treatment are closely observed throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinical stage III B/ III C with unsuitable for radical irradiation, Clinical stage IV or recurrent non-small cell lung cancer
• • 2. Life expectancy of at least 3 months
• • 3. Patients with ECOG performance status 0 or 1
• Exclusion Criteria:
• • 1. Patients with severe complication
• • 2. Patients with multiple primary cancers