Non-Small Cell Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc: SBRT
+ MK-3475
INN of investigational material: pembrolizumab
Therapeutic category code: 429 Other antitumor agents
Dosage and Administration for Investigational material:
- SBRT, every 3 days(Q3D), 3-5 f
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Has previously untreated NSCLC diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (AJCC 8th edition) by chest CT and PET scan 2)Cannot undergo thoracic surgery due to existing medical illness(es) or anatomically unresectable tumor as determined by the site's multidisciplinary tumor board. Medically operable participants who decide to treat with SBRT as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented 3)Has a ECOG Performance Status of 0, 1, or 2 4)Is able to receive SBRT and does not have an ultra-centrally located tumor 5)Has adequate organ function 6)A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/ placebo and 180 days after the last radiotherapy dose 7)Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor
Exclusion criteria
Exclusion criteria: 1)Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) 2)Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast.Participants receiving radiotherapy to the contralateral breast at least 5 years prior to randomization may still be eligible 3)Has received a live vaccine within 30 days prior to the first dose of study intervention 4)Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention administration 5)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 the first dose of study treatment 6)Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded 7)Has a known hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients 8)Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis 9)Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.No testing for hepatitis B and hepatitis C is required unless mandated by local health authority Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority 10)Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy 11)Has an active infection requiring systemic therapy 12)Has a known history of human immunodeficiency virus (HIV) infection 13)Has a known history of active tuberculosis (TB; Bacillus tuberculosis) 14)Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose 15)Has had an allogeneic tissue/solid organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - the Event-free Survival (EFS) : The time from randomization to an event defined as local, regional, or distant recurrence of the treated NSCLC or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall Survival(OS) : The time from randomization to death from any cause. - Time to death or distant metastases(TDDM) : The time from randomization to the first documented distant metastases or death from any cause, whichever occurs first. - safety and efficacy : Adverse events, Study intervention discontinuations due to AEs - global health status/quality of life(QoL) (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 items [QLQ-C30 Items] 29 and 30), cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 1), chest pain (EORTC QLQ-LC13 Item 10), dyspnea (EORTC QLQ-C30 Item 8), and physical functioning (EORTC QLQ-C30 Items 1-5). | — |
Countries
Asia except Japan, Europe, Japan, North America
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed