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

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: ONO-4538; Drug: Ramucirumab; Drug: ONO-4578; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06542731

ONO-4578-05

Details and patient eligibility

About

This study is PhaseⅠstudy to evaluate the tolerability and safety 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 NSCLC who were refractory to a combination therapy containing an anti-PD-(L)1 antibody and a platinum-based drug

Enrollment: 42 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab

Experimental group

Treatment:

Drug: Docetaxel

Drug: ONO-4578

Drug: Ramucirumab

Drug: ONO-4538