Non-small Cell Lung Cancer
Conditions
Keywords
Justice
Brief summary
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.
Interventions
DRUGCisplatin
Given on day 1 of every 21-day cycle.
DRUGCarboplatin
Given on day 1 of every 21-day cycle.
DRUGPemetrexed
Given on day 1 of every 21-day cycle.
DRUGPembrolizumab
Given on day 1 of every 21-day cycle. After cycle 4 is given every 6 weeks.
DRUGAbraxane
Given on days 1, 8, and 15 of each 21-day cycle.
DRUGPaclitaxel
Given on day 1 of every 21-day cycle.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Merck Sharp & Dohme LLC
Foundation Medicine
Go-2 Lung
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Have histologically or cytologically confirmed, advanced/metastatic NSCLC. * Be treatment naïve in the advanced/metastatic/recurrent disease setting. * No known EGFR/ALK/ROS1 tumor mutations. Liquid biopsies are acceptable. * Patients who received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or definitive chemoradiation and/or neoadjuvant and/or adjuvant immunotherapy and/or consolidation immunotherapy therapy given for locally advanced disease and developed recurrent (local or metastatic) disease ≥ 6 months of completing therapy are eligible. * Be planned/eligible to receive first-line therapy in the advanced/metastatic setting. * Have testing status for PDL1 tissue status. * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with any grade endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible. * Adequate organ function. * Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 180 days after the last dose if treated with pembrolizumab plus chemotherapy, or 120 days after the last dose if treated with pembrolizumab monotherapy. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. * Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 180 days after the last dose if treated with pembrolizumab plus chemotherapy. Cohorts 1, 2a and b:
Exclusion criteria
* 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. Cohort 2a and b Only:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Real World Overall Survival (rwOS) | Up to 36 Months | 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. |
| Cohort 2 Arm A: Progression Free Survival (PFS) | Up to 36 Months | Progression free survival is defined as the length of time from date of patient starts treatment to date of progression event or death. |
| Cohort 2 Arm B: Progression Free Survival (PFS) | Up to 36 Months | Progression free survival is defined as the length of time from date of patient starts treatment to date of progression event or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Baseline ctDNA | At Baseline | Baseline ctDNA will be summarized by mean, median, minimum, maximum, standard deviation, and coefficient of variation. |
| Cohort 2: Arm A and Arm B Objective Response Rate (ORR) | Up to 36 Months | Objective response rate will be determined by summing the rates of complete response and partial response. |
| Cohort 2: Arm A and Arm B Overall Survival (OS) | Up to 36 Months | 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. |
Countries
United States
Contacts
CONTACTAnahid Aminpour
PRINCIPAL_INVESTIGATORJhanelle Gray, MD
Moffitt Cancer Center
Outcome results
None listed