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 — Phase 1, Completed, 42 participants, Ono Pharmaceutical Co., Ltd.

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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

Registry	NCT06542731
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	42 (Actual)
Sponsor	Ono Pharmaceutical Co., Ltd. (Industry)
Conditions	Non-small Cell Lung Cancer
Interventions	ONO-4578, ONO-4538, Docetaxel, Ramucirumab (Drug)
Dates	start 2021-06-01, primary completion 2025-10-30, completion 2025-10-30, first posted 2024-08-07, last updated 2026-10-20
Locations	13 sites in Japan

-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

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+Arms and interventions

Arm	Type	Interventions	Description
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab	Experimental	Drug: ONO-4578; Drug: ONO-4538; Drug: Docetaxel; Drug: Ramucirumab

ONO-4578 (Drug): Specified dose on specified days
ONO-4538 (Drug), also known as Nivolumab: Specified dose on specified days
Docetaxel (Drug), also known as Taxotere: Specified dose on specified days
Ramucirumab (Drug), also known as Cyramza: Specified dose on specified days

+Outcome measures

Primary outcomes

Dose-limiting toxicities（DLT） [21 days]
Adverse event(AE) [Up to 28 days after the last dose]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 20 Years to any

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

+Locations (13)

Facility	City	Country
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

+Investigators

Project Leader, Study director, Ono Pharmaceutical Co., Ltd.