Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
This study tests a combination of lower-dose chemotherapy with an immunotherapy drug called anti-PD-1 in older adults with advanced lung cancer that has spread. The main goal is to see how many patients can tolerate this treatment combination without having to stop chemotherapy due to side effects.
Key Objective:This trial is testing whether using reduced-dose chemotherapy combined with immunotherapy can be effective while causing fewer serious side effects in vulnerable older patients.
Who to Consider:Older adults with advanced non-small cell lung cancer that has recurred or spread, whose tumor has low PD-L1 expression (less than 50%), and who may be too frail for standard full-dose chemotherapy should consider enrolling.
Trial Parameters
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Brief Summary
Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS\<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous) * Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation * No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable. * Age 70 or meeting frailty definition or above at the date of signing informed consent * Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell) * PD-L1 tumor proportion score (TPS) of less than 50% * Eastern Cooperative Oncology Group (ECOG) PS of 0-3 * Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment * Absolute neutrophil count (ANC) ≥ 1,000/μL * Platelets ≥ 75,000/μL * Hemoglobin (Hgb)