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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Wake Forest University Health Sciences • ClinicalTrials.gov ID: NCT04253964

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Pembrolizumab (Drug)
    ALL PARTICIPANTS: Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle for 4 cycles.
  • Atezolizumab (Drug)
    ALL PARTICIPANTS: 1,200 mg IV on day 1 over 60 minutes of each 3-week cycle for 4 cycles. If the first infusion is tolerated, then all subsequent infusions (cycles 2-4) may be delivered over 30 minutes. The subcutaneous formulation of atezolizumab may be substituted for the intravenous formulation as follows: Atezolizumab hyaluronidase-tqjs 15 mL (1,875 mg atezolizumab and 30,000 units hyaluronidase) subcutaneously into the thigh over 7 minutes on day 1 of each 3-week cycle for 4 cycles.
  • Cemiplimab-Rwlc (Drug)
    ALL PARTICIPANTS: 350 mg IV over 30 minutes on day 1 of each 3-week cycle for 4 cycles.
  • Carboplatin (Drug)
    FOR PARTICIPANTS IN EITHER ARM with non-squamous or squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous or squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles. AUC dosing (5-6) will be selected by the treating provider.
  • Paclitaxel (Drug)
    FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
  • Nab paclitaxel (Drug)
    FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles.
  • Pemetrexed (Drug)
    FOR PARTICIPANTS IN EITHER ARM with non-squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
  • Cisplatin (Drug)
    FOR PARTICIPANTS IN EITHER ARM with non-squamous or squamous subtype, predictive biomarker PD-L1 ≥50%, and the treating clinician has opted for combination chemo/immunotherapy OR non-squamous or squamous subtype, predictive biomarker PD-L1 1-49% or unknown: Cisplatin 75 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
  • Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13) (Other)
    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
  • QLQ-C30 Global Health/Quality of Life Questionnaire (Other)
    30 item questionnaire - Functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures.
  • COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes (Other)
    Dyspnea scale scores in patients with respiratory disease (particularly COPD) to establish baseline functional dyspnea burden (taken pre-study at Week 0 and Post Treatment at week 13).
  • PROMIS and FACT-G Questionnaires (Other)
    PROMIS 4-item short forms: Fatigue, Sleep Disturbance, Anxiety, and Depression as well as 1 item from the FACT-G which has been established as a valid indicator of treatment side effect bother ("I am bothered by side effects of treatment"); 17 symptom burden questions in total.
  • Sleep Disorder Assessments (ISI, Berlin Sleep Questionnaire) (Other)
    7 items on the Insomnia Severity Index (ISI) and 10 items from the Berlin Sleep Questionnaire, a risk assessment for obstructive sleep apnea.

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 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.

Conditions

Nonsmall Cell Lung Cancer Performance Status

Locations

  • Levine Cancer Institute — Charlotte, North Carolina, United States
  • Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record