Pembrolizumab treatment for advanced non-small cell lung cancer in patients with poor performance status

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label trial aims to evaluate the effects of pembrolizumab, an anti-PD-1 therapy, on the quality of life of patients with advanced non-small cell lung cancer (NSCLC) who are not eligible for standard treatments due to poor performance status. The study will enroll 45 patients with an ECOG performance status of 2 or 3 and assess changes in quality of life over a 12-week period using validated questionnaires. Secondary objectives include evaluating clinical outcomes, toxicity, and the impact of demographic factors on quality of life and clinical results.

Why it matters

Who can join: the full rules

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

Where it's running

• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Deborah Doroshow, MD, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Deborah Doroshow, MD, PhD
• Email: deborah.doroshow@mssm.edu
• Phone: 212-241-5615

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC

  This trial tests whether adding zoldonrasib to standard pembrolizumab and platinum chemotherapy helps people with untreated metastatic non-squamous NSCLC that has a RAS G12D mutation.

  Recruiting at 4 sites Phase 3 Revolution Medicines, Inc. · Anchorage, Alaska and 3 other locations · NCT07777822

• Pumitamig vs pembrolizumab for first-line advanced NSCLC with PD‑L1 ≥50% (ROSETTA Lung-202)

  This will test if pumitamig works better than pembrolizumab as the first treatment for people with advanced non-small cell lung cancer and PD‑L1 levels of 50% or higher.

  Recruiting at 180 sites Phase 3 Bristol-Myers Squibb · Daphne, Alabama and 282 other locations · NCT07361510

• Combining sacituzumab tirumotecan with pembrolizumab for advanced lung cancer

  This study is testing if combining two cancer treatments, sacituzumab tirumotecan and pembrolizumab, can help people with advanced lung cancer live longer compared to just using pembrolizumab alone.

  Recruiting at 154 sites Phase 3 Merck Sharp & Dohme LLC · Phoenix, Arizona and 219 other locations · NCT06170788

• Comparing two treatments for advanced lung cancer

  This study is testing whether a new drug called sotorasib with chemotherapy works better than pembrolizumab with chemotherapy for people with advanced lung cancer that has a specific KRAS mutation.

  Recruiting at 312 sites Phase 3 Amgen · Santa Barbara, California and 417 other locations · NCT05920356

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

  This study tests whether adding SBRT to standard lenvatinib plus pembrolizumab helps people with metastatic kidney cancer who have stable disease after initial treatment.

  Recruiting at 8 sites Phase 2 Kidney Cancer Research Bureau · Kazan' and 7 other locations · NCT07928167

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.