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

NCT06542731 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-08-07

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

ONO-4578

Specified dose on specified days

DRUG

ONO-4538

Specified dose on specified days

DRUG

Docetaxel

Specified dose on specified days

DRUG

Ramucirumab

Specified dose on specified days

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2026-09-12
Completion
2026-12-31

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06542731 on ClinicalTrials.gov