Non-Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
A Phase II Study of the Effects of Pembrolizumab on Quality of Life for Patients With Treatment-Naïve, Advanced or Metastatic NSCLC and Poor Performance Status
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | October 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 - Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists. - Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. - Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS directed therapy is not required and is unlikely to be required during the first cycle of therapy. - Patients with HIV on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial. - Adequate organ and marrow function as defined below: - Leukocytes = 3,000/mcL - Absolute neutrophil count = 1,000/mcL - Platelets = 100,000/mcl - Total bilirubin = 1.5 x ULN - AST (SGOT)/ALT (SPGT) = 3 x ULN or =5 x ULN if liver metastases present - GFR (Cockroft-Gault) = 30 mL/min - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 3 days prior to C1D1 of pembrolizumab therapy. For the purposes of this trial, WOCBP are defined as women who have had a menstrual period within the last 48 months. - Provision of signed and dated informed consent form - Ability to take the study medication, and complete the study questionnaires - Stated willingness to comply with all study procedures for the duration of the study - For women of reproductive potential, agreement to use highly effective contraception during study treatment and for at least 4 months after the final dose - For men of reproductive potential, agreement to use condoms or other methods to ensure effective contraception with female partners of reproductive potential Exclusion Criteria: - 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 - Pregnant or lactating patients |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and 12 weeks post-treatment | |
Secondary | 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. | Baseline and 6 weeks post-treatment | |
Secondary | 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. |
Baseline and 6 weeks post-treatment | |
Secondary | 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. |
Baseline and 12 weeks post-treatment | |
Secondary | 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. | Baseline and 6 weeks post-treatment | |
Secondary | Change in Hospital Anxiety and Depression Scale (HADS) Quality of Life (QOL) score | Change in Quality of Life (QOL) score at 12 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. | Baseline and 12 weeks post-treatment | |
Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time from the first dose of study treatment to the date of death (whatever the cause). | at 12 weeks post-treatment | |
Secondary | Objective Response Rate | Objective response rate, as determined by independent radiology review and assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Complete Response (CR) Disappearance of all target lesions for a period of at least one month. Partial Response (PR) At least a 30% decrease in the sum of the longest diameter of measures lesions (target lesions), taking as reference the baseline sum of the longest diameter. Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started. Progressive Disease (PD) A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
at 12 weeks post-treatment | |
Secondary | Progression-Free Survival (PFS) | Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to the first occurrence of disease progression or death on study from any cause, whichever occurs earlier | at 12 weeks post-treatment | |
Secondary | Number of Emergency Room Visits | Number of Emergency Room Visits | at 12 weeks post-treatment | |
Secondary | Number of Hospitalizations | Number of Hospitalizations | at 12 weeks post-treatment | |
Secondary | Number of Adverse Events | Number of Adverse events, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | at 12 weeks post-treatment | |
Secondary | Patient Reported Eastern Cooperative Oncology Group (ECOG) performance status | Patient reported Eastern Cooperative Oncology Group (ECOG) performance status (PS). The ECOG measures level of functioning in terms of daily living abilities: 0-Fully active, able to carry on all pre-disease performance without restriction Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg.light house work Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about >50% of waking hours Capable of only limited selfcare; confined to bed or chair >50% of waking hours Completely disabled; cannot carry on any selfcare; totally confined to bed or chair Dead |
at 12 weeks post-treatment | |
Secondary | Physician reported ECOG Performance Status Scale | Treating physician clinical assessment of performance status, as measured by the ECOG Performance Status Scale The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. |
at 12 weeks post-treatment | |
Secondary | Cancer Aging and Research Group (CARG) Chemo-Toxicity Calculator Survey Score | Geriatric assessment at baseline for patients 70 years of age and older, using the Cancer Aging and Research Group (CARG) Chemo-Toxicity Calculator Survey https://www.mycarg.org/?page_id=4480. CARG scores can range from 0 to 19, with a higher score indicating higher risk of chemotherapy toxicity. CARG scores from 0 to 5 are considered low risk, 6 to 9 are considered intermediate risk, and 10 to 19 are considered high risk. | Baseline | |
Secondary | Patient Reported Outcome (PRO) completion rate | PRO completion rate as measured by the percentage of survey instrument questions answered | at 12 weeks post-treatment |
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