Pembrolizumab and Chemotherapy for Advanced Non-Small Cell Lung Cancer

This study is looking at whether a combination of pembrolizumab (an immunotherapy drug) and a single chemotherapy drug (either pemetrexed or nab-paclitaxel) is safe and effective for people with locally advanced or metastatic non-small cell lung cancer. This study is for patients who have an ECOG Performance Status of 2, meaning you have some limitations in daily activities or spend up to half your day resting. Researchers will be monitoring side effects and how well participants tolerate the treatment over 18 months. The study aims to enroll about 60 participants. The current recruitment status is unclear.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll about 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events (side effects) for 18 months.

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NCT04297605

Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Rochester
~60 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:PembrolizumabPemetrexed (Chemotherapy)Nab-paclitaxel (Chemotherapy)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Measured over 18 Months
Non-small Cell Lung Cancer
2 sites across 1 states
New York2
  • Megan Baumgart · PRINCIPAL_INVESTIGATOR · University of Rochester

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Eligibility criteria

Inclusion

Amenorrheic for \<2 years and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation
Post hysterectomy, oophorectomy or tubal ligation. Otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study drug
  • Number of participants with Adverse Events as a Measure of Safety and Tolerability18 Months

    Determine the rate of treatment-limiting toxicities in patients with advanced non-small cell lung cancer with ECOG PS 2 who are treated with pembrolizumab and single-agent chemotherapy