Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-07
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Dose-limiting toxicities（DLT）
timeFrame: 21 days
measure: Adverse event(AE)
timeFrame: Up to 28 days after the last dose
Secondary outcomes:
measure: Pharmacokinetics（Plasma concentration of ONO-4578）
timeFrame: Up to 28 days after the last dose
measure: Pharmacokinetics（serum concentration of ONO-4538）
timeFrame: Up to 28 days after the last dose
measure: Overall response rate (ORR)
timeFrame: Up to 2 years
measure: Disease control rate (DCR)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Duration of response (DOR)
timeFrame: Up to 2 years
measure: Time to response (TTR)
timeFrame: Up to 2 years
measure: Best overall response (BOR)
timeFrame: Up to 2 years
measure: Percentage of change in the sum of tumor diameters of target lesions
timeFrame: Up to 2 years
measure: Maximum percentage of change in the sum of tumor diameters of target lesions
timeFrame: Up to 2 years
measure: Changes in tumor markers（CYFRA,CEA,SLX）
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Ina
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
city: Kiyose-shi
country: Japan
facility: Japan Anti-Tuberculosis Association Fukujuji Hospital
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital
city: Osaka-shi
country: Japan
facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: