Non Small Cell Lung Cancer
Conditions
Keywords
PD-L1 High, 19-030, Memorial Sloan Kettering Cancer Center
Brief summary
The purpose of this study is to attempt to obtain an on-treatment biopsy in participants with non-small cell lung cancer who are receiving standard treatment with a drug that targets the PD-1 or PD-L1 protein.
Interventions
DIAGNOSTIC_TESTPre-Treatment Biopsy
Participants screened for participation will include those with a diagnosis of advanced NSCLC who have undergone a pre-treatment biopsy prior to start of therapy with a PD-(L)1 inhibitor or who are medically able to undergo a biopsy if (1) no pre-treatment biopsy has been obtained and (2) no PD-(L)1 inhibitor has been started.
DIAGNOSTIC_TESTOn-Treatment Biopsy
All participants who receive at least 1 dose of PD-(L)1 inhibitor will be referred for a biopsy. The biopsy should be obtained within 4 weeks of first on-treatment imaging (usually performed \ 6-9 weeks after beginning therapy) and will be performed in participants regardless of radiologic response.
DIAGNOSTIC_TESTBiopsy at Disease Progression
All participants who develop disease progression after initial response to PD-(L)1 blockade will be considered for an additional, optional biopsy. Biopsies at disease progression are often obtained per standard of care within 4 weeks of documented progression on imaging and prior to the initiation of further systemic therapy.
DIAGNOSTIC_TESTPeripheral Blood-Based Studies
All participants will have peripheral blood obtained on Day 1 of cycles 1-4 (0, 3, 6, and 9 weeks). At each time point, peripheral blood sample will be collected pre-treatment and used for analysis of T cell subsets and TCR sequencing.
Sponsors
Wang Initiative in Lung Cancer Clinical Trials
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed newly diagnosed or recurrent advanced Non Small Cell Lung Cancer/NSCLC that is PI-L1 high by immunohistochemistry (PD-L1 \>/= 50%) * Intended treatment with a PD-(L)1 inhibitor * Age \>/= 18 years * Karnofsky Performance Status \>/= 70% and medically fit to undergo a biopsy procedure
Exclusion criteria
* Any medical condition or any sites of disease that would preclude a biopsy * Pregnant or breastfeeding women * Cognitively impairment affecting ability to understand and provide informed consent * Prior PD-(L)1 blockade treatment * Chemotherapy within 6 months prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC | 24 weeks |
Countries
United States
Outcome results
None listed