Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

About this trial

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

Qualifiers

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

Disqualifiers

Participants with life expectancy of less than 3 months at the time of enrollment

Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)

Diagnosis of interstitial lung disease

Creatinine clearance of <30 mL/min

Trial design

Treatments tested in this trial

  • Reduced Dose of Chemotherapy and Immunotherapy

Treatment groups

40 Participants
are divided into 1 treatment group