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

ConditionNon-small Cell Lung Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Cisplatin

    Drug

    Given on day 1 of every 21-day cycle.

  • Carboplatin

    Drug

    Given on day 1 of every 21-day cycle.

  • Pemetrexed

    Drug

    Given on day 1 of every 21-day cycle.

  • Pembrolizumab

    Drug

    Given on day 1 of every 21-day cycle. After cycle 4 is given every 6 weeks.

  • Abraxane

    Drug

    Given on days 1, 8, and 15 of each 21-day cycle.

  • Paclitaxel

    Drug

    Given on day 1 of every 21-day cycle.

Treatment groups

318 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 6 interventions
Group B: Cohort 2: arm AExperimental treatment 1 intervention
Group C: Cohort 2: arm BExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Cohort 1: Real World Overall Survival (rwOS)

Real-world overall survival (rwOS) is defined as the length of time from the date the patient initiates treatment to the date of death or end of follow up, whichever occurred earliest.

Time frame
Up to 36 Months
2

Cohort 2 Arm A: Progression Free Survival (PFS)

Progression free survival is defined as the length of time from date of patient starts treatment to date of progression event or death.

Time frame
Up to 36 Months
3

Cohort 2 Arm B: Progression Free Survival (PFS)

Progression free survival is defined as the length of time from date of patient starts treatment to date of progression event or death.

Time frame
Up to 36 Months

Secondary outcomes

1

Cohort 1: Baseline ctDNA

Baseline ctDNA will be summarized by mean, median, minimum, maximum, standard deviation, and coefficient of variation.

Time frame
At Baseline
2

Cohort 2: Arm A and Arm B Objective Response Rate (ORR)

Objective response rate will be determined by summing the rates of complete response and partial response.

Time frame
Up to 36 Months
3

Cohort 2: Arm A and Arm B Overall Survival (OS)

Overall Survival is defined as the length of time from the date the patient initiates treatment to the date of death or end of follow up, whichever occurred earliest.

Time frame
Up to 36 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Foundation Medicine

Collaborator

Go-2 Lung

Collaborator

Source ClinicalTrials.gov
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