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

August 5, 2024 updated by: Ono Pharmaceutical Co. Ltd

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Bunkyo-ku, Japan
        • Juntendo University Hospital
      • Itabashi-ku, Japan
        • Teikyo University Hospital
      • Kiyose-shi, Japan
        • Japan Anti-Tuberculosis Association Fukujuji Hospital
      • Koto-ku, Japan
        • The Cancer Institute Hospital of JFCR
      • Niigata-shi, Japan
        • Niigata Cancer Center Hospital
      • Nishinomiya-shi, Japan
        • Hyogo Medical University Hospital
      • Osaka-shi, Japan
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
      • Sagamihara-shi, Japan
        • Kitasato University Hospital
      • Sakai, Japan
        • National Hospital Organization Kinki-Chuo Chest Medical Center
      • Takatsuki-shi, Japan
        • Osaka Medical and Pharmaceutical University Hospital
      • Yokohama-shi, Japan
        • Kanagawa Cancer Center
    • Saitama
      • Ina, Saitama, Japan
        • Saitama Cancer Center
    • Tokyo
      • Chuo Ku, Tokyo, Japan
        • National Cancer Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab
Drug: Docetaxel
Specified dose on specified days
Other Names:
  • Taxotere
Drug: Ramucirumab
Specified dose on specified days
Other Names:
  • Cyramza
Drug: ONO-4538
Specified dose on specified days
Other Names:
  • Nivolumab
Drug: ONO-4578
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicities（DLT）
Time Frame: 21 days
21 days
Adverse event(AE)
Time Frame: Up to 28 days after the last dose
Up to 28 days after the last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 2 years
Up to 2 years
Progression-free survival (PFS)
Time Frame: Up to 2 years
Up to 2 years
Overall response rate (ORR)
Time Frame: Up to 2 years
Up to 2 years
Duration of response (DOR)
Time Frame: Up to 2 years
Up to 2 years
Time to response (TTR)
Time Frame: Up to 2 years
Up to 2 years
Disease control rate (DCR)
Time Frame: Up to 2 years
Up to 2 years
Best overall response (BOR)
Time Frame: Up to 2 years
Up to 2 years
Percentage of change in the sum of tumor diameters of target lesions
Time Frame: Up to 2 years
Up to 2 years
Maximum percentage of change in the sum of tumor diameters of target lesions
Time Frame: Up to 2 years
Up to 2 years
Pharmacokinetics（Plasma concentration of ONO-4578）
Time Frame: Up to 28 days after the last dose
Up to 28 days after the last dose
Pharmacokinetics（serum concentration of ONO-4538）
Time Frame: Up to 28 days after the last dose
Up to 28 days after the last dose
Changes in tumor markers（CYFRA,CEA,SLX）
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

September 12, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4578-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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