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 1Active Not RecruitingNCT06542731

Ono Pharmaceutical Co. Ltd42 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

ONO-4578DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

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

...and 3 more locations

Outcomes

Primary Outcomes

Dose-limiting toxicities（DLT）

Time frame: 21 days

Adverse event(AE)

Time frame: Up to 28 days after the last dose

Secondary Outcomes

Pharmacokinetics（Plasma concentration of ONO-4578）

Time frame: Up to 28 days after the last dose

Pharmacokinetics（serum concentration of ONO-4538）

Time frame: Up to 28 days after the last dose

Overall response rate (ORR)

Time frame: Up to 2 years

Disease control rate (DCR)

Time frame: Up to 2 years

Overall survival (OS)

Time frame: Up to 2 years

Progression-free survival (PFS)

Time frame: Up to 2 years

Duration of response (DOR)

Time frame: Up to 2 years

Time to response (TTR)

Time frame: Up to 2 years

Best overall response (BOR)

Time frame: Up to 2 years

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

Time frame: Up to 2 years

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

Time frame: Up to 2 years

Changes in tumor markers（CYFRA,CEA,SLX）

Time frame: Up to 2 years