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Can a cancer drug boost quality of life for the sickest lung cancer patients?

NCT ID NCT05589818

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

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