Carcinoma, Non-Small-Cell LungPhase 1/2NCT02422381
MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing MK-3475 and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by Providence Health & Services at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- MK-3475 and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jul 2015to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence Oncology & Hematology Care Clinic - Eastside
Portland, Oregon, 97213
Providence Oncology & Hematology Care Clinic - Westside
Portland, Oregon, 97225
About this study
Official title: A Phase I/II Study of MK-3475 With Gemcitabine in Patients With Previously-Treated Advanced 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.
Read the detailed description
This study is an open-label, non-randomized phase I study, followed by open-label non-randomized phase II study. The first cohort of patients will receive 200 milligrams (mg) of MK-3475 by intravenous infusion over a 21-day period called a cycle along with Gemcitabine 1250 mg/m2 given on Days 1 and 8 of each 21-day cycle for up to 6 cycles. Patients will be seen in the study clinic 12 times over 126 days for an evaluation of signs and symptoms that may represent drug toxicity. Patients may continue to receive MK-3475 (without gemcitabine) for up to 2 years.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- MK-3475, Gemcitabine
- Keywords
- NSCLC, lung cancer, Gemzar, Pembrolizumab, Anti-PD-1, Immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-3475Drug
Also called Anti-PD-1, Pembrolizumab
Investigational drug.
GemcitabineDrug
Also called Gemzar
Standard care drug.
| Study group | Role | What they receive |
|---|---|---|
| MK-3475 + Gemcitabine | Experimental | 200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles. Receives: Drug: MK-3475; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
Patients are seen in clinic 12 times over 126 days to determine any changes in signs or symptoms that may represent drug toxicity. Drug toxicity is defined as events that required holding or delaying treatment.
Measured: 126 Days (six 21-day cycles)
Secondary outcomes (3)
Progression Free Survival
Patients will have CT scans after every two cycles for up to 2 years to assess changes in tumor sizes.
Measured: 2 years
Overall Survival
Patients will be contacted every 12 weeks following end of treatment to determine survival status until death, withdrawal of consent, or the end of the study, whichever occurs first.
Measured: Every 12 weeks (up to 2 years)
Disease Response
Patients will have CT scans to assess changes in tumor sizes.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start20 Jul 2015
- Primary completion9 Jan 2019
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Providence Cancer Center, Earle A. Chiles Research Institute
- Responsible party
- Sponsor
- Investigators
- Rachel Sanborn, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422381
- Sponsor's protocol ID
- 15-011A
- Status last verified
- Jan 2026
- First submitted
- 20 Mar 2015
- Last updated
- 18 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of MK-3475 With Gemcitabine in Patients With Previously-Treated Advanced Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02422381
- Acronym / sponsor ID
- 15-011A
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC, lung cancer, Gemzar, Pembrolizumab, Anti-PD-1, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Providence Cancer Center, Earle A. Chiles Research Institute
- Study start
- 20 Jul 2015 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is an open-label, non-randomized phase I study, followed by open-label non-randomized phase II study. The first cohort of patients will receive 200 milligrams (mg) of MK-3475 by intravenous infusion over a 21-day period called a cycle along with Gemcitabine 1250 mg/m2 given on Days 1 and 8 of each 21-day cycle for up to 6 cycles. Patients will be seen in the study clinic 12 times over 126 days for an evaluation of signs and symptoms that may represent drug toxicity. Patients may continue to receive MK-3475 (without gemcitabine) for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-3475 + Gemcitabine | Experimental | Drug: MK-3475, Drug: Gemcitabine200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-3475Also: Anti-PD-1, PembrolizumabInvestigational drug. | Drug | MK-3475 + Gemcitabine |
| GemcitabineAlso: GemzarStandard care drug. | Drug | MK-3475 + Gemcitabine |
Primary outcome
Dose Limiting Toxicities
Time frame: 126 Days (six 21-day cycles)
Patients are seen in clinic 12 times over 126 days to determine any changes in signs or symptoms that may represent drug toxicity. Drug toxicity is defined as events that required holding or delaying treatment.
3 secondary outcomes
Progression Free Survival
Time frame: 2 years
Overall Survival
Time frame: Every 12 weeks (up to 2 years)
Disease Response
Time frame: up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Providence Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Sanborn, MD principal investigator
Providence Health & Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MK-3475 and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by Providence Health & Services at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (time frame: 126 Days (six 21-day cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.