Pembrolizumab for Advanced NSCLC and PS 2-3
ConditionNon-Small Cell Lung Cancer (NSCLC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This single center open-label trial will enroll a single cohort of patients with advanced non-small cell lung cancer (NSCLC) who are ineligible for treatment with curative intent due to 1) disease stage IV, or 2) inability to tolerate intensive surgery or chemo-radiation. Patients will be eligible for the trial if ISMMS reviewed samples from tumor biopsy have a PDL-1 TPS ≥ 1% and have ECOG performance status rated 2 or 3. All patients will receive anti PD-1 therapy with pembrolizumab 200mg IV every 3 weeks, during which patients will also undergo serial QOL assessments.
This trial will follow a phase II single arm, open label design. The study will enroll 45 patients evaluable for the primary endpoint of which will be change in QOL as measured by the EORTC's QLQ-C30 between Day 1 and Day 84 +/- 7 days. Secondary outcomes including evaluation for development of confounding mental health conditions will be evaluated via serial HADS assessments. Concomitant radiographic assessment with PET/CT, regardless of the doses of pembrolizumab received, will allow for evaluation of secondary efficacy outcomes, including disease response by RECIST 1.1 criteria.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women, aged 18 years and older, with locally advanced NSCLC who are ineligible for definitive surgical resection or concurrent chemoradiation, or metastatic NSCLC
Patients must not have received any systemic therapy for metastatic cancer
Patients must not have received any PD-1 or PD-L1 inhibitor
ECOG performance status of 2 or 3 at the time of consent and on the first day of therapy
Disqualifiers
Autoimmune conditions requiring >10mg prednisone (or its equivalent) of daily therapy or other systemic immunosuppressive therapy.
Patients who are receiving other investigational agents
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
Patients with known leptomeningeal disease for which CNS therapy is required
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab
DrugPatients will be treated with the standard dose of pembrolizumab for the first 12 weeks of the study. After week 12 assessments, patients without objective progression of disease are eligible to transition to Q6W dosing of pembrolizumab 400mg IV. Patients will be offered this schedule, also an FDA-approved option, at the discretion of the treating physician, based on tolerability of the q3week regimen and clinician assessment of need for closer follow up intervals. Pembrolizumab will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: PembrolizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in EORTC QLQ-C30 Quality of Life score
Change in quality of life (QOL) score at 12 weeks post-treatment compared to baseline with pembrolizumab as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The scale ranges from 1=very poor to 7 = excellent. The higher the score the better the quality of life.
Time frame
Baseline and 12 weeks post-treatmentSecondary outcomes
1
Change in EORTC QLQ-C30 Quality of Life score
Change in Quality of Life (QOL) score at 6 weeks post-treatment compared to baseline with pembrolizumab as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The scale ranges from 1=very poor to 7 = excellent. The higher the score the better the quality of life.
Time frame
Baseline and 6 weeks post-treatment2
Change in EORTC's QLQ-LC13 Quality of Life (QOL) score
Change in Quality of Life (QOL) score at 6 weeks post-treatment compared to baseline with pembrolizumab as measured by EORTC's QLQ-LC13. The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms.
Time frame
Baseline and 6 weeks post-treatment3
Change in EORTC's QLQ-LC13 Quality of Life (QOL) score
Change in Quality of Life (QOL) score at 12 weeks post-treatment with pembrolizumab as measured by EORTC's QLQ-LC13. The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms.
Time frame
Baseline and 12 weeks post-treatment4
Change in Hospital Anxiety and Depression Scale (HADS) Quality of Life (QOL) score
Change in Quality of Life (QOL) score at 6 weeks post-treatment in the emotional domain as measured by HADS. HADS is 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Time frame
Baseline and 6 weeks post-treatmentSponsors and contacts
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Source ClinicalTrials.gov