JRCT ID: jRCT2021220015
Registered date:02/07/2022
A Phase 3 study of MK-7684A plus cCRT in Stage III NSCLC
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | NSCLC |
Date of first enrollment | 06/10/2022 |
Target sample size | 50 |
Countries of recruitment | USA,Japan,Brazil,Japan,Guatemala,Japan,Costa Rica,Japan,Mexico,Japan,Chile,Japan,Germany,Japan,Italy,Japan,Spain,Japan,Portugal,Japan,Israel,Japan,Russia,Japan,Turkey,Japan,Ukraine,Japan,Greece,Japan,Romania,Japan,Netherlands,Japan,Australia,Japan,Malaysia,Japan,South Korea,Japan,China,Japan |
Study type | Interventional |
Intervention(s) | - Intervention 1: Participants will receive MK-7684A (coformulation of MK-7684 200mg and MK-3475 200mg) IV Q3W in combination with 3 cycles of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy followed by MK-7684A for up to 17 cycles. - Intervention 2: Participants will receive 3 cycles of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy followed by durvalumab 10 mg/kg IV Q2W for up to 26 cycles. |
Outcome(s)
Primary Outcome | - Progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) - Overall Survival (OS) |
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Secondary Outcome | - Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR - Safety and tolerability - Duration of Response (DOR) per RECIST 1.1 as assessed by BICR - Mean change from baseline in global health status(GHS)/quality of life (QoL), physical functioning, dyspnea, cough, and chest pain - Time-to-true Deterioration (TTD) in GHS/QoL, physical functioning, dyspnea, cough, and chest pain |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | - Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC. - Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8 - Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon - Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain - Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review - Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC - Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional]) - Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention - Has a life expectancy of at least 6 months |
Exclude criteria | - Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible - Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer - Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention - Is expected to require any other form of antineoplastic therapy, while on study - Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention - Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention - Is 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 - Has a 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 prior to the first dose of study medication - Has a known additional malignancy that is progressing or has required active treatment within the past 5 years - Has an active autoimmune disease that has required systemic treatment in past 2 years - Has a 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) infection - Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection - Has had an allogenic tissue/solid organ transplant - Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose <=1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed - Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone |
Related Information
Primary Sponsor | Ishii Takeaki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05298423 |
Contact
Public contact | |
Name | MSDJRCT inquiry mailbox |
Address | KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |
Scientific contact | |
Name | Takeaki Ishii |
Address | KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |