Study of Two Doses of MK-3475 (Pembrolizumab) Versus Docetaxel in Previously-Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    II/III What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 13-000268
  • NCT ID:

    NCT01905657
  • Sponsor Protocol Number:

    MK-3475-010

About this study

This study will compare two doses of pembrolizumab versus docetaxel in participants with non-small cell lung cancer (NSCLC) who have experienced disease progression after platinum-containing systemic therapy. Participants will be assigned randomly to receive either Low Dose or High Dose pembrolizumab every three weeks (Q3W), or docetaxel at 75 mg/m^2 Q3W. This study will use an adaptive trial design so that the total number of participants randomized will depend upon demonstration of sufficient objective responses at interim analysis. If the pembrolizumab Low Dose arm is closed, participants may receive pembrolizumab High Dose therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Life expectancy of at least 3 months
  • Histologically- or cytologically-confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review
  • At least one bi-dimensional measurable lesion
  • Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet
  • Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

  • Prior therapy with docetaxel for NSCLC
  • Receiving systemic steroid therapy within three days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication
  • Expected to require any other form of systemic or localized antineoplastic therapy while on trial
  • History of allogeneic tissue/solid organ transplant
  • Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of >30 Gray within 6 months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug
  • Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways), or took part in another pembrolizumab trial
  • Known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
  • Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment
  • Known history or active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of pembrolizumab or 180 days after last dose of docetaxel

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Julian Molina, M.D., Ph.D.

Closed for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015