Effectiveness and Safety of Pembrolizumab for Participants with Resectable Stage IIB or IIIA Non-small Cell Lung Cancer

Overview

About this study

This trial will evaluate the safety and effectiveness 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 IIB or IIIA non-small cell lung cancer (NSCLC).

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 during the treatment period and for the time needed to eliminate
each study intervention after the last dose of study intervention.

- 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
the time needed to eliminate each study intervention after the last dose of study
intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store
for her own use for the purpose of reproduction during this period.

- 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:

- 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.

Eligibility last updated 6/2/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

Contact information:

Stephanie Abel CCRP

(507)538-3476

Abel.Stephanie@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Yanyan Lou, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

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