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ACTIVE NOT RECRUITING
NCT06542731
PHASE1

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

Sponsor: Ono Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

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

Official title: Phase 1 Study of ONO-4578 Given as Combinations of ONO-4578, ONO-4538, Docetaxel and Ramucirumab in Subjects With Metastatic Non-small Cell Lung Cancer Who Have Had Disease Progression During or After One Prior First-line Anti-PD-(L) 1 Antibody and Platinum-based Chemotherapy for Advanced/Metastatic Disease

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2021-06-01

Completion Date

2026-12-31

Last Updated

2024-08-07

Healthy Volunteers

No

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

Locations (13)

Saitama Cancer Center

Shinden, Saitama, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Juntendo University Hospital

Bunkyō City, Japan

Teikyo University Hospital

Itabashi-ku, Japan

Japan Anti-Tuberculosis Association Fukujuji Hospital

Kiyose-shi, Japan

The Cancer Institute Hospital of JFCR

Kōtoku, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Hyogo Medical University Hospital

Nishinomiya-shi, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Osaka, Japan

Kitasato University Hospital

Sagamihara-shi, Japan

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-shi, Japan

Kanagawa Cancer Center

Yokohama, Japan