Non-small Cell Lung Cancer
Conditions
Interventions
Investigational materials
Generic name etc: MK-3475, Cisplatin, Gemcitabine, Pemetrexed
INN of investigational material: Pembrolizumab, Cisplatin, Gemcitabine, Pemetrexed
Therapeutic category code: 42
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC. - 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - Event Free Survival (EFS) [Time Frame: Up to 5 years] EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by blinded central pathologist or by imaging using RECIST 1.1 assessed by BICR. - Overall Survival (OS) [Time Frame: Up to 5 years] OS is defined as the time from randomization until death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Efficacy - Major Pathological Response (mPR) Rate [Time Frame: Up to 7 weeks following completion of neoadjuvant treatment (up to Study Week 20)] mPR rate is defined as the percentage of participants having <=10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. - Pathological Complete Response (pCR) Rate [Time Frame: Up to 7 weeks following completion of neoadjuvant treatment (up to Study Week 20)] pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. - Global Health Status/Quality of Life (GHS/QoL) Score using the European Organization for Research and Treatment (EORTC) QoL Questionnaire (QLQ-C30) [Time Frame: Baseline (cycle 1 in neoadjuvant phase) and end of follow-up (up to 5 years)] Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL. - Adverse Events (AEs) [Time Frame: Up to 71 weeks] The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study t | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed