Comparing treatment outcomes in lung cancer patients with different performance statuses

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

This study is testing if immunotherapy treatments can help lung cancer patients with lower performance status feel better and live longer compared to those with better performance status.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT04253964 on ClinicalTrials.gov

What this trial studies

This pilot study aims to compare the efficacy and safety of immunotherapy-based treatments in non-small cell lung cancer patients with Performance Status 2 against those with Performance Status 0-1. The primary objective is to demonstrate that the progression-free survival rate at 12 weeks for Performance Status 2 patients is not inferior to that of Performance Status 0-1 patients. Secondary objectives include assessing treatment-related adverse events, quality of life changes, and deterioration in lung-cancer specific symptoms between the two groups. The study utilizes a regimen including Pembrolizumab, Carboplatin, and Paclitaxel, along with quality of life assessments.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with metastatic or unresectable non-small cell lung cancer and an ECOG performance status of 0-2.

Not a fit: Patients who have previously received systemic treatment for non-curative intent or those with a life expectancy of less than 3 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence that patients with poorer performance status can safely receive effective treatments for lung cancer.

How similar studies have performed: Other studies have shown promising results in treating patients with varying performance statuses, suggesting that this approach may be viable.

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 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 indicated9; 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). For non-squamous subtypes, molecular testing of tumor and peripheral blood should be attempted for actionable biomarkers, but if there is an insufficient quantity of tumor material for testing and it is not feasible to attempt additional biopsies before starting systemic therapy, then these biomarker results are not necessary for inclusion on the study. For squamous subtype, molecular testing should be considered but is not necessary for inclusion on the study.
* 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.

Where this trial is running

Winston-Salem, North Carolina

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Thomas Lycan, Jr., D.O., M.H.S. — Wake Forest University Health Sciences
• Study coordinator: Study Coordinator

Conditions Nonsmall Cell Lung Cancer; Performance Status