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KEYNOTE-799: A phase 2 trial of pembrolizumab (mk-3475), in combination with platinum doublet chemotherapy and radiotherapy, for participants with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC)

Description

This is a trial in adult participants with unresectable, locally advanced, stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop grade 3 or higher pneumonitis is ≤10 percent.

Status

Coming soon

Primary Study Objective(s)

The study's primary objective is to: 

  • Evaluate, within each platinum doublet chemotherapy cohort, the percentage of participants who develop grade 3 or higher pneumonitis
  • Estimate, within each platinum doublet chemotherapy cohort, the objective response rate as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are male or female, at least 18 years of age on the day of signing informed consent with previously untreated, pathologically confirmed NSCLC and stage IIIA, IIIB or IIIC NSCLC by the American Joint Committee on Cancer Version 8
  • Have no evidence of metastatic disease by whole body positron emission tomography/computed tomography (PET/ CT) scan, diagnostic quality CT scan, and brain imaging
  • Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
  • Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have adequate pulmonary function test (PFT)
  • Have adequate organ function
  • Are male and agree to use contraception through the end of treatment and refrain from donating sperm during this period
  • Are female and are not pregnant, not breastfeeding, and if of childbearing potential (WOCBP), agrees to follow the contraceptive guidance as provided in the protocol through the end of treatment

Excluding patients who:

  • Are WOCBP who have had a positive urine pregnancy test within 72 hours prior to treatment allocation
  • Have small cell lung cancer
  • Have had documented weight loss >10% in the preceding 3 months
  • Have radiation treatment plans that are likely to encompass a volume of whole lung receiving >20 Gy in total (V20) of more than 31% of lung volume
  • Have received prior radiotherapy to the thorax, including radiotherapy to the esophagus or for breast cancer
  • Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent (programmed cell death protein 1 [PD-1] and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 [PD-L2]) or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
  • Have received a live vaccine within 30 days prior to the first dose of study drug
  • Have had an allogenic tissue/solid organ transplant
  • Are currently participating in, or have participated in, a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment
  • Have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
  • Have a known additional malignancy that is progressing or have required active treatment within the past 5 years
  • Have severe hypersensitivity (grade 3 or higher) to pembrolizumab and/or any of its excipients
  • Have a known severe hypersensitivity (grade 3 or higher) to any of the study chemotherapy agents and/or to any of their excipients
  • Have an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids
  • Have an active infection requiring systemic therapy
  • Have a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by a local health authority
  • Have 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
  • Have a known history of active tuberculosis (TB; Bacillus tuberculosis)
  • Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Have a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study
  • Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study through the end of treatment

Learn more about lung cancer

     

Coming soon

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Theodore Pollock