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New treatment option for Non-Small Cell Lung Cancer (NSCLC)
Official title Pembrolizumab for Advanced NSCLC and PS 2-3
ClinicalTrials.gov ID: NCT05589818
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer (nsclc).
Also referred to as PD-1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women, aged 18 years and older, with locally advanced NSCLC who are ineligible for definitive surgical resection or concurrent...
- 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...
You likely can't join if
- 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...
- Patients with known leptomeningeal disease for which CNS therapy is required
- Pregnant or lactating patients
See the full eligibility 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...
- 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...
- 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...
- 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
- 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...
- Patients with known leptomeningeal disease for which CNS therapy is required
- Pregnant or lactating patients
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.