Trial Search Results

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

The purpose of this study is to:·Study how pembrolizumab (MK-3475), in combination with chemotherapyand surgery, works in your body and against your cancer; Test the safety of the study drug, pembrolizumab (MK-3475), to see how well the drug works and how your body handles the drug.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Merck Sharp & Dohme Corp.

Stanford Investigator(s):

Intervention(s):

  • Biological: Pembrolizumab
  • Drug: Placebo
  • Drug: Cisplatin
  • Drug: Gemcitabine
  • Drug: Pemetrexed

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or
   IIIB (N2) NSCLC.

   - Be able to undergo protocol therapy, including necessary surgery. A positron emission
   tomography (PET) scan may be utilized as a surrogate for pathologic staging of N1
   lymph nodes for participants with T2b and T4 tumors.

   - If male, must agree to use contraception or practice abstinence as well as refrain
   from donating sperm for at least 180 days after the last dose of study treatment.

   - If female, may participate if not pregnant, not breastfeeding, and at least one of the
   following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a
   WOCBP who agrees to follow contraceptive guidance during the treatment period and for
   at least 180 days after the last dose of study treatment.

   - Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for
   submission. If blocks are not available, have unstained slides for submission for
   central programmed death-ligand 1 (PD-L1) testing.

   - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within
   10 days of randomization.

   - Have adequate organ function.

Exclusion Criteria:

   - A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose
   of study treatment.

   - Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus;
   2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.

   - Has a history of (non-infectious) pneumonitis /interstitial lung disease that required
   steroids or has current pneumonitis/interstitial lung disease that requires steroids.

   - Has an active infection requiring systemic therapy.

   - Has had an allogenic tissue/sold organ transplant.

   - Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance
   and/or any of its excipients.

   - Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy
   agents and/or to any of their excipients.

   - Has an active autoimmune disease that has required systemic treatment in past 2 years.

   - Has a known history of human immunodeficiency virus (HIV) infection.

   - Has a known history of Hepatitis B or Hepatitis C.

   - Has a known history of active tuberculosis.

   - Has a history or current evidence of any condition, therapy, or laboratory abnormality
   that might confound the results of the trial, interfere with the participant's
   participation for the full duration of the trial, or is not in the best interest of
   the participant to participate.

   - Has known psychiatric or substance abuse disorders that would interfere with
   cooperating with the requirements of the trial.

   - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with
   an agent directed to another co-inhibitory T-cell receptor.

   - Has received prior systemic anti-cancer therapy including investigational agents for
   the current malignancy prior to randomization/allocation.

   - Has received prior radiotherapy within 2 weeks of start of trial treatment.

   - Has received a live vaccine within 30 days prior to the first dose of trial drug.

   - Is currently participating in or has participated in a trial of an investigational
   agent or has used an investigational device within 4 weeks prior to the first dose of
   trial treatment.

   - Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or
   any other form of immunosuppressive therapy within 7 days prior the first dose of
   trial drug.

   - Has a known additional malignancy that is progressing or requires active treatment
   within the past 5 years.

   - Is pregnant or breastfeeding or expecting to conceive or father children within the
   projected duration of the trial, starting with the screening visit through 180 days
   after the last dose of trial treatment.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Olga Generalova
650-498-5188
Recruiting