Can a cancer drug boost quality of life for the sickest lung cancer patients?
NCT ID NCT05589818
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether the immunotherapy drug pembrolizumab can improve quality of life for people with advanced non-small cell lung cancer who are not healthy enough for standard treatments. The trial will enroll 45 patients who have not had prior cancer therapy and have a poor performance status (ECOG 2 or 3). Participants will receive pembrolizumab every three weeks, and their quality of life will be measured using a standard questionnaire over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab (a drug that helps the immune system fight cancer)
- What this could lead to
- If successful, this could show that pembrolizumab improves quality of life for people with advanced lung cancer who are too weak for standard treatments.
- What could go wrong
- This is a small, early-phase study with no comparison group, so results may not be conclusive. Pembrolizumab can cause immune-related side effects like inflammation of the lungs, colon, or skin.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mount Sinai Hospital
RECRUITINGNew York, New York, 10029, United States
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