MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)

NCT02422381 | Active Not Recruiting Phase 1 Results

• 1 other identifier: 15-011A
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC; lung cancer; Gemzar; Pembrolizumab; Anti-PD-1; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  126 Days (six 21-day cycles)

Secondary Outcomes (3)

• Progression Free Survival

  2 years

• Overall Survival

  Every 12 weeks (up to 2 years)

• Disease Response

  up to 2 years

Study Arms (1)

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.

Drug: MK-3475; Drug: Gemcitabine

Interventions

MK-3475 DRUG

Investigational drug.

Also known as: Anti-PD-1, Pembrolizumab

MK-3475 + Gemcitabine

Gemcitabine DRUG

Standard care drug.

Also known as: Gemzar

MK-3475 + Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Providence Health & Services: lead
• Merck Sharp & Dohme LLC: collaborator
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator

Study Sites (2)

Providence Oncology & Hematology Care Clinic - Eastside

Portland, Oregon, 97213, United States

Location

Providence Oncology & Hematology Care Clinic - Westside

Portland, Oregon, 97225, United States

Location

Related Links

• Providence Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

pembrolizumab; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Rachel Sanborn
• Organization: Earle A. Chiles Research Institute, Providence Cancer Institute

canrsrchstudies@providence.org

503-215-1979

Study Officials

• Rachel Sanborn, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: April 21, 2015
• Study Start: July 20, 2015
• Primary Completion: January 9, 2019
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)