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NCT Number: NCT06542731

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Saitama Cancer Center, Shinden, Saitama, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical stage III B/ III C with unsuitable for radical irradiation, Clinical stage IV or recurrent non-small cell lung cancer
  • Life expectancy of at least 3 months
  • Patients with ECOG performance status 0 or 1

Exclusion criteria

  • Patients with severe complication
  • Patients with multiple primary cancers

Treatment and study plan

ONO-4578

Drug

Specified dose on specified days

ONO-4538

Drug

Specified dose on specified days

Other names: Nivolumab

docetaxel

Drug

Specified dose on specified days

Other names: Taxotere

Ramucirumab

Drug

Specified dose on specified days

Other names: Cyramza

Primary outcomes

  1. Dose-limiting toxicities（DLT）

    Time frame: 21 days

  2. Adverse event(AE)

    Time frame: Up to 28 days after the last dose

Secondary outcomes

  1. Pharmacokinetics（Plasma concentration of ONO-4578）

    Time frame: Up to 28 days after the last dose

  2. Pharmacokinetics（serum concentration of ONO-4538）

    Time frame: Up to 28 days after the last dose

  3. Overall response rate (ORR)

    Time frame: Up to 2 years

  4. Disease control rate (DCR)

    Time frame: Up to 2 years

  5. Overall survival (OS)

    Time frame: Up to 2 years

  6. Progression-free survival (PFS)

    Time frame: Up to 2 years

  7. Duration of response (DOR)

    Time frame: Up to 2 years

  8. Time to response (TTR)

    Time frame: Up to 2 years

  9. Best overall response (BOR)

    Time frame: Up to 2 years

  10. Percentage of change in the sum of tumor diameters of target lesions

    Time frame: Up to 2 years

  11. Maximum percentage of change in the sum of tumor diameters of target lesions

    Time frame: Up to 2 years

  12. Changes in tumor markers（CYFRA,CEA,SLX）

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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