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Phase 3 study of SBRT ± pembrolizumab for participants with unresected Stage I or IIA NSCLC

Title Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Unresected Stage I or IIA Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)
Therapeutic Area Non Small Cell Lung Cancer
Principal Investigator Kathryn Huber, MD
Min Age 18 Years
Gender Any
Contact Sarah Sexton
More Information


This is a multisite, placebo-controlled, randomized, double-blind study designed to compare the efficacy and safety of SBRT + pembrolizumab versus SBRT + placebo in participants with unresected Stage I or IIA NSCLC. Eligible patients must have histologically or cytologically confirmed Stage I or IIA NSCLC that has not been previously treated.

Study Details

Inclusion Criteria

  1. Has previously untreated NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA NSCLC 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.
  3. Has an ECOG performance status of 0, 1, or 2.

Exclusion Criteria

  1. Women of Child-Bearing Potential who has a positive urine pregnancy test within 72 hours prior to randomization or treatment allocation
  2. 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 coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  3. 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.

Study Requirements

After a screening phase, each eligible participant will be randomized in a 1:1 ratio to receive SBRT + pembrolizumab 200 mg every 3 weeks for 17 cycles or SBRT + placebo every 3 weeks for 17 cycles. All randomized patients will receive either pembrolizumab or placebo regardless if they complete SBRT. After the end of treatment, each participant will be followed for the occurrence of adverse events and other occurrences. All participants will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study.