Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected Stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC). The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).

Key facts

Study ID

NCT03924869

Run by

Merck Sharp & Dohme LLC

People needed

448

Starts

2019-06-25

Expected to finish

2025-01-20

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded
• Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented
• Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• Is able to receive SBRT and does not have an ultra-centrally located tumor
• Has adequate organ function within 7 days prior to the start of study treatment
• 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
• Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic
• Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor

You may not qualify if…

• Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 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. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137])
• Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast
• Has received a live vaccine within 30 days prior to the first dose of study intervention
• Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention administration
• 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
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
• Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• Has a known history of Hepatitis B or known active Hepatitis C virus infection
• Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
• 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
• Have not adequately recovered from major surgery or have ongoing surgical complications
• Has had an allogenic tissue/solid organ transplant

Where it is running

• Infirmary Cancer Care ( Site 3044) — Mobile, Alabama, United States
• Alaska Oncology and Hematology ( Site 3063) — Anchorage, Alaska, United States
• Banner MD Anderson Cancer Center ( Site 3029) — Gilbert, Arizona, United States
• CARTI Cancer Center ( Site 3045) — Little Rock, Arkansas, United States
• USC Norris Comprehensive Cancer Center ( Site 0007) — Los Angeles, California, United States
• Veterans Affairs Palo Alto Health Care System ( Site 3039) — Palo Alto, California, United States
• National Jewish Health ( Site 0010) — Denver, Colorado, United States
• Yale University ( Site 0011) — New Haven, Connecticut, United States
• Mid Florida Hematology and Oncology Center ( Site 0067) — Orange City, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute ( Site 0016) — Tampa, Florida, United States
• Goshen Center for Cancer Care ( Site 0022) — Goshen, Indiana, United States
• Franciscan Health Indianapolis ( Site 0024) — Indianapolis, Indiana, United States
• University of Kentucky School of Medicine & Hospitals ( Site 0026) — Lexington, Kentucky, United States
• Sinai Hospital of Baltimore ( Site 3011) — Baltimore, Maryland, United States
• William E. Kahlert Regional Cancer Center ( Site 3031) — Westminster, Maryland, United States
• Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007) — Boston, Massachusetts, United States
• Mass General / North Shore Center for Outpatient Care ( Site 3040) — Danvers, Massachusetts, United States
• University of Massachusetts ( Site 0029) — Worcester, Massachusetts, United States
• Sanford Bemidji ( Site 0080) — Bemidji, Minnesota, United States
• University of Minnesota ( Site 0069) — Minneapolis, Minnesota, United States
• University of Missouri Hospital ( Site 3058) — Columbia, Missouri, United States
• Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060) — Springfield, Missouri, United States
• St. Vincent Healthcare Frontier Cancer Center ( Site 3012) — Billings, Montana, United States
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036) — Hackensack, New Jersey, United States
• University of Alabama ( Site 0099) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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