This phase II trial studies how well immunotherapy (pembrolizumab, atezolizumab, or cemiplimab) with or without chemotherapy (cisplatin, carboplatin, pemetrexed, paclitaxel, nab-paclitaxel) works in treating patients with non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and have a performance status of 2 compared to a performance status of 0-1. Performance status is a measure used by doctors to describe how much cancer has impacted a patient’s daily living abilities. Immunotherapy with monoclonal antibodies, such as pembrolizumab, atezolizumab, or cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid and may kill cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. The purpose of this research is to see whether or not the standard treatment regimen of immunotherapy, with or without chemotherapy, can help patients who are less physically functional as much as it helps patients who are more physically functional.
Additional locations may be listed on ClinicalTrials.gov for NCT04253964.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Thomas William Lycan
Phone: 336-716-0230
PRIMARY OBJECTIVE:
I. To demonstrate that proportion of performance status 2 (PS2) participants with progression-free survival at 12 weeks is not inferior to the corresponding proportion of performance status 0-1 (PS0-1) patients.
SECONDARY OBJECTIVES:
I. To demonstrate that incidence of treatment-related adverse events at 12 weeks in the PS2 group is not higher than that occurring in the PS0-1 groups.
II. To demonstrate that change in overall quality of life (QOL)/global health status (GHS) at 12 weeks is not inferior in the PS2 group compared to the change in the PS0-1 group.
III. To demonstrate that proportion of participants with deterioration in lung-cancer specific symptoms at 12 weeks in the PS2 group is not higher than the corresponding proportion in the PS0-1 group.
EXPLORATORY OBJECTIVES:
I. To examine whether overall response rate is non-inferior in the PS2 group compared to the PS0-1 group.
II. To examine whether median overall survival is non-inferior in the PS2 group compared to the PS0-1 group.
III. To examine whether change in lung-cancer-specific QOL measures at 12 weeks is non-inferior in the PS2 group compared to the PS0-1 group.
IV. To examine whether change in chronic obstructive pulmonary disease (COPD) functional status 12 weeks is non-inferior in the PS2 group compared to the PS0-1 group.
V. To collect serum samples from pre-treatment, post-treatment, and follow-up for future studies of laboratory correlatives.
VI. To examine change in symptom patient-reported outcomes after 4 cycles of treatment and compare between PS2 and PS0-1 groups.
VII. To assess risk for clinical sleep disorders at baseline and after 4 cycles of treatment in the PS2 group and the PS0-1 group.
OUTLINE:
IMMUNOTHERAPY: Patients receive either pembrolizumab intravenously (IV) over 30 minutes, atezolizumab IV over 30-60 minutes or subcutaneously (SC) over 7 minutes, or cemiplimab IV over 30 minutes on day 1 of each cycle per the treating clinician discretion. Cycles repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
CHEMOTHERAPY: Patients are assigned to 1 of 2 arms.
ARM I: In addition to the above immunotherapy, patients with non-squamous tumor subtype, PD-L1 < 49% or unknown, and PD-L1 ≥ 50% receive either carboplatin IV or cisplatin IV on day 1 of each cycle per treating clinician discretion, as well as pemetrexed IV on day 1 of each cycle. Cycles repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: In addition to the above immunotherapy, patients with squamous subtype, PD-L1 < 49% or unknown, and PD-L1 ≥ 50% receive either carboplatin IV or cisplatin IV on day 1 of each cycle per treating clinician discretion, as well as paclitaxel IV on day 1 or nab-paclitaxel IV on days 1, 8, and 15 of each cycle per treating clinician discretion. Cycles repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Patients in all arms undergo blood sample collection throughout the study.
After the completion of study treatment, patients are followed up for 30 days, then up to 3 months.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorThomas William Lycan
