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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

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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)

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

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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