A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

Purpose

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

Condition

  • Carcinoma, Non-Small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

The main inclusion criteria include but are not limited to the following: - Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition] - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention - Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible - Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R]) - Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART) - Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization - Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria

The main exclusion criteria include but are not limited to the following: - Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor - Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements - Received prior neoadjuvant therapy for their current NSCLC diagnosis - Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137) - Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol - Received prior treatment with a cancer vaccine - Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pembrolizumab + Intismeran autogene 		For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via intravenous (IV) infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC] 5 or 6 mg/mL/min, pemetrexed 500 mg/m^2, gemcitabine 1000 mg/m^2, paclitaxel 175 mg/m^2 or 200 mg/m^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to ~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to ~42 weeks).
  • Biological: Pembrolizumab
    IV Infusion
    Other names:
    • MK-3475
    • KEYTRUDA®
  • Drug: Cisplatin
    IV infusion
    Other names:
    • Platinol®
    • Platinol®-AQ
  • Drug: Carboplatin
    IV infusion
    Other names:
    • Paraplatin®
  • Drug: Pemetrexed
    IV infusion
    Other names:
    • Alimta®
  • Drug: Gemcitabine
    IV infusion
    Other names:
    • Gemzar
  • Drug: Paclitaxel
    IV infusion
    Other names:
    • Taxol®
    • Onxol®
  • Biological: Intismeran autogene
    IM injection
    Other names:
    • mRNA-4157
    • V940
Active Comparator
Pembrolizumab + Placebo 		For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via IV infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m^2 or carboplatin AUC 5 or 6 mg/mL/min, pemetrexed 500 mg/m^2, gemcitabine 1000 mg/m^2, paclitaxel 175 mg/m^2 or 200 mg/m^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to ~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS matching placebo via IM injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to ~42 weeks).
  • Biological: Pembrolizumab
    IV Infusion
    Other names:
    • MK-3475
    • KEYTRUDA®
  • Drug: Cisplatin
    IV infusion
    Other names:
    • Platinol®
    • Platinol®-AQ
  • Drug: Carboplatin
    IV infusion
    Other names:
    • Paraplatin®
  • Drug: Pemetrexed
    IV infusion
    Other names:
    • Alimta®
  • Drug: Gemcitabine
    IV infusion
    Other names:
    • Gemzar
  • Drug: Paclitaxel
    IV infusion
    Other names:
    • Taxol®
    • Onxol®
  • Other: Placebo
    IM injection

Recruiting Locations

Banner MD Anderson Cancer Center ( Site 0181)
Gilbert 5295903, Arizona 5551752 85234
Contact:
Study Coordinator
480-256-6444

Providence St. Jude Medical Center ( Site 0106)
Fullerton 5351247, California 5332921 92835
Contact:
Study Coordinator
714-446-5900

VA Long Beach Healthcare System ( Site 0199)
Long Beach 5367929, California 5332921 90822
Contact:
Study Coordinator
562-826-8000

USC Norris Comprehensive Cancer Center ( Site 0205)
Los Angeles 5368361, California 5332921 90033
Contact:
Study Coordinator
323-865-3000

UCSF Medical Center at Mission Bay ( Site 0178)
San Francisco 5391959, California 5332921 94158
Contact:
Study Coordinator
888-577-8839

UCHealth Memorial Hospital Central ( Site 0125)
Colorado Springs 5417598, Colorado 5417618 80909
Contact:
Study Coordinator
719-365-5000

Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)
Greeley 5577592, Colorado 5417618 80631
Contact:
Study Coordinator
970-810-3894

Centura Health - St. Anthony North Health Campus ( Site 0189)
Westminster 5443910, Colorado 5417618 80023
Contact:
Study Coordinator
720-627-4840

Yale University School of Medicine ( Site 0201)
New Haven 4839366, Connecticut 4831725 06510
Contact:
Study Coordinator
203-785-7564

Eastern CT Hematology & Oncology Associates ( Site 0202)
Norwich 4839843, Connecticut 4831725 06360
Contact:
Study Coordinator
860-886-8362

The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)
Fort Lauderdale 4155966, Florida 4155751 33316
Contact:
Study Coordinator
954-771-0692

Beacon Cancer Care ( Site 0127)
Post Falls 5604353, Idaho 5596512 83854
Contact:
Study Coordinator
888-577-8839

The University of Chicago Medical Center ( Site 0118)
Chicago 4887398, Illinois 4896861 60637
Contact:
Study Coordinator
773-702-2984

Maryland Oncology Hematology (MOH) ( Site 8102)
Rockville 4367175, Maryland 4361885 20850
Contact:
Study Coordinator
570-808-4772

Massachusetts General Hospital ( Site 0136)
Boston 4930956, Massachusetts 6254926 02114
Contact:
Study Coordinator
617-724-4000

Dana Farber Cancer Hospital ( Site 0155)
Boston 4930956, Massachusetts 6254926 02215
Contact:
Study Coordinator
888-577-8839

Ellis Fischel Cancer Center ( Site 0133)
Columbia 4381982, Missouri 4398678 65212
Contact:
Study Coordinator
573-882-7440

Lake Regional Hospital-Cancer Center ( Site 0123)
Osage Beach 4402040, Missouri 4398678 65065
Contact:
Study Coordinator
573-302-2772

Roswell Park Cancer Institute ( Site 0184)
Buffalo 5110629, New York 5128638 14263
Contact:
Study Coordinator
716-845-3167

Hematology-Oncology Associates of CNY ( Site 0164)
East Syracuse 5116079, New York 5128638 13057
Contact:
Study Coordinator
888-577-8839

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)
New York 5128581, New York 5128638 10011
Contact:
Study Coordinator
202-207-2510

Icahn School of Medicine at Mount Sinai ( Site 0116)
New York 5128581, New York 5128638 10029
Contact:
Study Coordinator
212-523-5559

Memorial Sloan Kettering Cancer Center ( Site 0137)
New York 5128581, New York 5128638 10065
Contact:
Study Coordinator
888-577-8839

SUNY Upstate Cancer Center ( Site 0140)
Syracuse 5140405, New York 5128638 13210
Contact:
Study Coordinator
315-464-8237

Montefiore Medical Center ( Site 0160)
The Bronx 5110266, New York 5128638 10461
Contact:
Study Coordinator
888-577-8839

Westchester Medical Center ( Site 0196)
Valhalla 5142090, New York 5128638 10595
Contact:
Study Coordinator
914-493-7000

University of Cincinnati Medical Center ( Site 0119)
Cincinnati 4508722, Ohio 5165418 45219
Contact:
Study Coordinator
513-558-2119

St. Lukes Hospital and Health Network ( Site 0186)
Bethlehem 5180225, Pennsylvania 6254927 18015
Contact:
Study Coordinator
888-577-8839

Thompson Cancer Survival Center ( Site 0168)
Knoxville 4634946, Tennessee 4662168 37916
Contact:
Study Coordinator
865-331-1720

Elliston Place Medical Oncology & Hematology ( Site 0215)
Nashville 4644585, Tennessee 4662168 37203
Contact:
Study Coordinator
615-961-9469

Texas Oncology - DFW ( Site 8103)
Dallas 4684888, Texas 4736286 75246
Contact:
Study Coordinator
214-370-1987

Houston Methodist Cancer Center ( Site 0191)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
713-363-8890

MD Anderson Cancer Center ( Site 0150)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
888-577-8839

Memorial Hermann Cancer Center ( Site 0172)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
713-704-3961

O'Quinn Medical Tower at McNair Campus ( Site 0131)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
832-957-6500

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)
Tyler 4738214, Texas 4736286 75701
Contact:
Study Coordinator
888-577-8839

Virginia Cancer Specialists ( Site 0167)
Fairfax 4758023, Virginia 6254928 22031
Contact:
Study Coordinator
571-350-8400

Swedish Cancer Institute ( Site 0143)
Seattle 5809844, Washington 5815135 98104
Contact:
Study Coordinator
855-922-6237

Virginia Mason Franciscan Health - St. Michael Cancer Center ( Site 0192)
Silverdale 5810490, Washington 5815135 98383
Contact:
Study Coordinator
564-240-3100

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com