Open-Label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK-7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC.
Primary Objective:
- To compare PFS per RECIST 1.1 as assessed by BICR.
- To compare OS.
Secondary Objectives:
- To compare MK-7684A with cCRT followed by MK-7684A to cCRT followed by durvalumab with respect to ORR per RECIST 1.1 as assessed by BICR in participants with TPS greater or less than 1% and PD-LI all-comer participants.
- To evaluate the safety and tolerability of MK-7684A with cCRT followed by MK-7684A compared to cCRT followed by durvalumab in all participants.
- To compare MK-7684A with cCRT followed by MK-7684A to cCRT followed by durvalumab with respect to DOR per RECIST 1.1 as assessed by BICR in participants with TPS greater or less than 1% and PD-LI all-comer participants.
- To evaluate the change from baseline in GHS/QoL, cough, chest pain,
dyspnea and physical functioning following treatment with MK-7684A with cCRT followed by MK-7684A compared to cCRT followed by durvalumab in participants with TPS greater or less than 1% and PD-L1 all-comer participants.
- To evaluate the TTD in GHS/QoL, cough, chest pain, dyspnea and physical functioning following treatment with MK-7684A with cCRT followed by MK-7684A compared to cCRT followed by durvalumab in participants with TPS greater or less than1% and PD-L1 all-comer participants.
MEDI4736 (Durvalumab)
Chemotherapy single agent systemic
- Rutgers Cancer Institute of New Jersey
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion 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
Exclusion 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
Pemetrexed-specific Criteria:
- 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.