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

NCT ID: NCT06542731

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ONO-4578+ONO-4538+docetaxel + ramucirumab

Group Type EXPERIMENTAL

ONO-4578

Intervention Type DRUG

Specified dose on specified days

ONO-4538

Intervention Type DRUG

Specified dose on specified days

Docetaxel

Intervention Type DRUG

Specified dose on specified days

Ramucirumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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ONO-4578

Specified dose on specified days

Intervention Type DRUG

ONO-4538

Specified dose on specified days

Intervention Type DRUG

Docetaxel

Specified dose on specified days

Intervention Type DRUG

Ramucirumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Nivolumab Taxotere Cyramza

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Saitama Cancer Center

Shinden, Saitama, Japan

Site Status

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Site Status

Juntendo University Hospital

Bunkyō City, , Japan

Site Status

Teikyo University Hospital

Itabashi-ku, , Japan

Site Status

Japan Anti-Tuberculosis Association Fukujuji Hospital

Kiyose-shi, , Japan

Site Status

The Cancer Institute Hospital of JFCR

Kōtoku, , Japan

Site Status

Niigata Cancer Center Hospital

Niigata, , Japan

Site Status

Hyogo Medical University Hospital

Nishinomiya-shi, , Japan

Site Status

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Osaka, , Japan

Site Status

Kitasato University Hospital

Sagamihara-shi, , Japan

Site Status

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai, , Japan

Site Status

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-shi, , Japan

Site Status

Kanagawa Cancer Center

Yokohama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-4578-05

Identifier Type: -

Identifier Source: org_study_id

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