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

Phase 1

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: ONO-4578; Drug: ONO-4538; Drug: Docetaxel; Drug: Ramucirumab

• Registration Number: NCT06542731
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Primary Completion: 2026-09-12
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab	ONO-4578	-
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab	ONO-4538	-
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab	Docetaxel	-
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab	Ramucirumab	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities（DLT）	21 days
Adverse event(AE)	Up to 28 days after the last dose

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 2 years
Disease control rate (DCR)	Up to 2 years
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
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

Trial Locations

Locations (13)

National Cancer Center Hospital; 🇯🇵 Chuo Ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR; 🇯🇵 Koto-ku, Japan

Teikyo University Hospital; 🇯🇵 Itabashi-ku, Japan

Saitama Cancer Center; 🇯🇵 Ina, Saitama, Japan

Japan Anti-Tuberculosis Association Fukujuji Hospital; 🇯🇵 Kiyose-shi, Japan

Juntendo University Hospital; 🇯🇵 Bunkyo-ku, Japan

Niigata Cancer Center Hospital; 🇯🇵 Niigata-shi, Japan

Hyogo Medical University Hospital; 🇯🇵 Nishinomiya-shi, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute; 🇯🇵 Osaka-shi, Japan

National Hospital Organization Kinki-Chuo Chest Medical Center; 🇯🇵 Sakai, Japan

Kitasato University Hospital; 🇯🇵 Sagamihara-shi, Japan

Osaka Medical and Pharmaceutical University Hospital; 🇯🇵 Takatsuki-shi, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama-shi, Japan