New combo therapy aims to control advanced lung cancer
NCT ID NCT02422381
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with advanced non-small cell lung cancer who have already tried other treatments. Researchers are testing whether adding an experimental drug called MK-3475 to standard chemotherapy (gemcitabine) is safe and what dose works best. The goal is to control the disease and improve survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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16 people
The number who actually took part.
- Started
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Jul 2015
- Expected to finish
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Dec 2026
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: * 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. Exclusion Criteria: * 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.
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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.
Contacts and locations
Locations
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Providence Oncology & Hematology Care Clinic - Eastside
Portland, Oregon, 97213, United States
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Providence Oncology & Hematology Care Clinic - Westside
Portland, Oregon, 97225, United States
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