Phase 3 study of SBRT +- pembrolizumab for participants with unresected Stage I or II NSCLC

Phase 3

Completed

Conditions: on-Small Cell Lung Cancer

Registration Number: JPRN-jRCT2080224826

Lead Sponsor: MSD K.K.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: completed

Sex: All

Target Recruitment: 530

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

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