Comparing treatment outcomes in lung cancer patients with different performance statuses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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). 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 it's running

• Levine Cancer Institute
  Charlotte, North Carolina, United States Recruiting
• 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: Project Manager
• Email: Melani.Terry@advocatehealth.org
• Phone: 336-716-5772

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.