A Phase 3 study of MK-7684A in combination with chemotherapy in metastatic NSCLC

JRCT ID: jRCT2031220098

Registered date:28/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 18/05/2022
• Target sample size: 46
• Countries of recruitment: USA,Japan,Mexico,Japan,Colombia,Japan,Chile,Japan,Brazil,Japan,Argentina,Japan,Austria,Japan,Germany,Japan,Israel,Japan,Poland,Japan,Russia,Japan,Spain,Japan,Turkey,Japan,Ukraine,Japan,France,Japan,UK,Japan,South Korea,Japan,China,Japan,Taiwan,Japan,Thailand,Japan
• Study type: Interventional

Intervention(s)

Participants will receive 4 cycles of MK-7684A (coformulation of MK-7684 200mg and MK-3475 200mg) or MK-3475 200mg Q3W in combination with chemotherapy followed by up to 31 cycles of MK-7684A or MK-3475 (including pemetrexed for participants with nonsquamous NSCLC) Q3W.

Platinum Doublet Chemotherapy:
- Participants with squamous NSCLC will receive 4 cycles of carboplatin with taxane (paclitaxel/nab-paclitaxel).
- Participants with nonsquamous NSCLC will receive 4 cycles of pemetrexed with platinum (cisplatin/carboplatin) followed by pemetrexed maintenance until progression, intolerable AE, or discontinuation by decision of participant or physician.

Outcome(s)

• Primary Outcome: - Overall Survival (OS)

Secondary Outcome

- Progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR)
- Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
- Mean change from baseline in global health status/quality of life (QoL), physical functioning, dyspnea, cough, and chest pain
- Time to True Deterioration (TTD) in global health status/QoL, physical functioning, dyspnea, cough, and chest pain
- Safety and tolerability
- Duration of Response (DOR) per RECIST 1.1 as assessed by BICR

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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.

Exclude criteria

- 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.

Related Information

• Primary Sponsor: Nohata Nijiro
• Secondary ID(s): NCT05226598