Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Wake Forest University Health Sciences
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Updated on 19 February 2024
See if I qualify
cancer
metastasis
carboplatin
pembrolizumab
neutrophil count
lung cancer
pemetrexed
paclitaxel
dyspnea
cancer treatment
carboplatin/paclitaxel
cancer therapy
non-small cell lung cancer
small cell lung cancer

Summary

This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.

Description

Primary Objective: To demonstrate that proportion of Performance Status 2 participants with progression-free survival at 12 weeks is not inferior to the corresponding proportion of Performance Status 0-1 patients.

Secondary Objective(s)

  • To demonstrate that incidence of treatment-related adverse events at 12 weeks in the Performance Status 2 group is not higher than that occurring in the Performance Status 0-1 groups.
  • To demonstrate that change in overall quality of life/global health status at 12 weeks is not inferior in the Performance Status 2 group compared to the change in the Performance Status 0-1 group.
  • To demonstrate that proportion of participants with deterioration in lung-cancer specific symptoms at 12 weeks in the Performance Status 2 group is not higher than the corresponding proportion in the Performance Status 0-1 group.

Details
Condition Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Performance Status
Age 18years - 100years
Treatment Carboplatin, Pembrolizumab, Pemetrexed, Paclitaxel, Nab paclitaxel, Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13), QLQ-C30 Global Health/Quality of Life Questionnaire, COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes
Clinical Study IdentifierNCT04253964
SponsorWake Forest University Health Sciences
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients must have histologically confirmed NSCLC that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
No prior systemic treatment with either chemotherapy or immunotherapy for non-curative intent. Patients may have previously received cancer treatment with curative intent for prior early stage disease
At least 18 years old
ECOG performance status of 0-2, as determined by the treating physician in the consult note
Life expectancy of greater than 3 months
Patients must have radiographically measurable metastatic disease by RECIST criteria
Patients must have normal organ and marrow function as defined below
absolute neutrophil count 1,000/mcL
platelets 100,000/mcL
Chemotherapy agents are known to be teratogenic, therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign an IRB-approved informed consent document

Exclusion Criteria

Nonsmall cell lung cancer that is known at registration to be positive for a tumor activating alteration for which first line targeted therapy is indicated; specifically, a targetable mutation in epidermal growth factor receptor (EGFR), gene rearrangement of anaplastic lymphoma kinase (ALK), gene rearrangement of c-ros oncogene 1 (ROS1), or mutation in B isoform of rapidly accelerated fibrosarcoma (B-Raf)
Known to have an active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, systemic corticosteroids, or immunosuppressive drugs)
History of (non-infectious) pneumonitis that required systemic corticosteroids
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued
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