MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)
This is a study for patients with previously-treated advanced non-small cell lung cancer (NSCLC). The study will evaluate the safety of adding an investigational drug, MK-3475 to standard treatment with gemcitabine. The study will also try to identify the best dose of MK-3475 to give in combination with gemcitabine.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Feb 18, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Providence Health & Services
- Interventions being studied
- Drug: MK-3475; Drug: Gemcitabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Women or men with advanced, histologically proven NSCLC.
- Patients must have received at least one but no more than three prior systemic therapies for advanced disease.
- Any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with anti-PD1 therapy or gemcitabine should be resolved to less than Grade 1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Women of childbearing potential must have a negative pregnancy test
- Ability to give informed consent and comply with the protocol.
- Anticipated survival minimum 3 months.
- Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
- Patients must have normal organ and marrow function as seen on protocol-defined blood test results
- Archived tumor tissue (minimum of 8 slides for paraffin-embedded tumor tissue) available
- Measurable disease by RECIST 1.1 criteria.
- Treated brain metastases will be allowed, provided they are asymptomatic.
- Radiation for symptomatic lesions outside the Central nervous system (CNS) must have been completed at least 2 weeks prior to study enrollment.
- Prior therapy with any anti-PD-1, anti-PD-L1, or anti-CTLA4 antibody.
- Prior therapy with gemcitabine.
- Prior complications from radiation, such as history of radiation pneumonitis or pulmonary edema that, in the opinion of the investigator, may have risk of increasing toxicity with anti-PD1 therapy.
- Active autoimmune disease except vitiligo or stable hypothyroidism.
- Active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, cardiopulmonary disease (COPD), allergic rhinitis).
- Active other malignancy, except for controlled basal cell skin carcinoma.
- HIV positive and/or Hepatitis B or C positive.
- Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in this protocol.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Providence Oncology & Hematology Care Clinic - EastsidePortland, Oregon
- Providence Oncology & Hematology Care Clinic - WestsidePortland, Oregon
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 18, 2026. Always confirm current availability with the study team.