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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jan 31, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how well patients with non-small cell lung cancer (NSCLC) who have a Performance Status (PS) of 2 respond to a specific treatment compared to those with a PS of 0-1. Performance Status is a way to measure how well a person can perform daily activities; a lower number means the person is healthier and more active. The study will compare the effectiveness and safety of a first-line treatment combining chemotherapy and immunotherapy for both groups to see if the outcomes are similar, especially in terms of living longer without the disease worsening and overall quality of life.

To be eligible for this trial, participants must be at least 18 years old and have a diagnosis of metastatic (advanced) or unresectable (unable to be surgically removed) non-small cell lung cancer. They should not have received prior treatments for their cancer that were not aimed at curing it, and they must have measurable cancer as determined by medical imaging. Participants will need to agree to use reliable birth control during the study and must be able to understand and sign a consent form. The study is currently recruiting participants and aims to provide important insights into how patients with different levels of health status respond to similar cancer treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must have a cytological or histological diagnosis of non-small cell lung cancer that is metastatic or unresectable for which standard curative measures do not exist.
• • 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.