Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

This is a non-registrational, cohort study enrolling eligible Black patients diagnosed with histologically or cytologically, advanced/metastatic NSCLC without known EGFR/ALK/ROS1 tumor mutations, and who are ≥ 18 years of age, ECOG performance status 0-2, and may have detectable ctDNA at baseline.

Eligibility criteria

Qualifiers

Be willing and able to provide written informed consent/assent.

Must be ≥ 18 years of age on day of signing informed consent.

Be Black / African American per self-report.

Have an ECOG performance status of 0- 2.

Disqualifiers

Does not plan or is ineligible to receive pembrolizumab with or without chemotherapy per institutional standard/treating provider.

History of allogenic tissue/solid organ transplant.

Received prior treatment chemotherapy and/or immune checkpoint inhibitor therapy in the advanced/metastatic setting for lung cancer.

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses

Trial design

Treatments tested in this trial

  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • Pembrolizumab
  • Abraxane
  • Paclitaxel

Treatment groups

318 Participants
are divided into 3 treatment groups

Sponsors and collaborators

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Foundation Medicine

Collaborator

Go-2 Lung

Collaborator