Pembrolizumab for Advanced NSCLC and PS 2-3
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how pembrolizumab affects quality of life in people with advanced non-small cell lung cancer who cannot have treatment meant to cure it. It is for adults whose health limits daily activities and whose tumor has a PD-L1 test score of at least 1%. Patients get the drug through a vein every 3 weeks and complete quality-of-life surveys.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older with non-small cell lung cancer that has spread, or locally advanced cancer that cannot be treated with surgery or chemotherapy and radiation together.
- No past whole-body drug treatment for cancer that has spread, and no past PD-1 or PD-L1 drugs. No gene changes with an FDA-approved targeted drug for first treatment.
- An ECOG score of 2 or 3, meaning health limits daily activities, both when joining and when treatment starts. A tumor sample reviewed by ISMMS must have a PD-L1 score of at least 1%.
- Cancer that has spread to the brain must be stable for at least 4 weeks after treatment. New or growing brain cancer, or cancer in the lining around the brain and spinal cord, may be allowed if the doctor says treatment there is not needed right away or likely during the first treatment cycle.
- Blood counts and liver and kidney tests must meet study limits. People with HIV may join if treatment is working and the virus was undetectable within the past 6 months.
- Women who could become pregnant must have a negative pregnancy test within 3 days before treatment. This includes women who had a period within the past 48 months.
- Women who could become pregnant must use highly effective birth control during treatment and for at least 4 months afterward. Men who could father a child must use condoms or another effective method with partners who could become pregnant.
- Must sign a consent form, be able to receive the drug and complete surveys, and agree to follow study steps.
Who can't join
- An autoimmune condition, where the immune system attacks the body, that needs more than 10 mg of prednisone daily, an equal dose of a similar drug, or other whole-body drugs that weaken the immune system.
- Taking another experimental treatment.
- An uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat; or mental health or social problems that would prevent following study steps.
- Cancer in the lining around the brain and spinal cord that needs treatment there.
- Pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
NY
- Mount Sinai Hospital · New York, NY 10029Katherine Vandris · Study contact · Katherine.Vandris@mssm.eduBailey Fitzgerald, MD · Study contact · Bailey.Fitzgerald@mountsinai.orgDeborah Doroshow · Principal investigatorMore trials in New York