A Phase 3 study of MK-7684A in combination with chemotherapy in metastatic NSCLC
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2031220098
- Lead Sponsor
- ohata Nijiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC.
- Has not received prior systemic treatment for metastatic NSCLC.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment.
- Has a life expectancy of at least 3 months.
- Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Severe hypersensitivity to vibostolimab, pembrolizumab, chemotherapy components, and/or any of its excipients.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
- Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus.
- Received prior systemic anticancer therapy for metastatic disease.
- Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- History of allogenic tissue/solid organ transplant.
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =< 1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- Is unable or unwilling to take folic acid or vitamin B12 supplementation.
- Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method