Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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
