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)

  • STATUS
    Recruiting
  • End date
    Jun 29, 2026
  • participants needed
    786
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 2 August 2021
Investigator
Toll Free Number
Primary Contact
Sanatorio Parque ( Site 0135) (0.0 mi away) Contact
+237 other location
pemetrexed
gemcitabine
pembrolizumab
cancer chemotherapy
solid tumour
mk-3475
platinum doublet
lung carcinoma

Summary

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent central review (BICR); and 2) overall survival (OS).

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment cisplatin, Placebo, Gemcitabine, Pembrolizumab, Pemetrexed
Clinical Study IdentifierNCT03425643
SponsorMerck Sharp & Dohme Corp.
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

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 neoadjuvant cisplatin
If female, may participate if not pregnant or 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
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