Recruiting
Phase 3

Pembrolizumab & V940

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06623422

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Cisplatin

Carboplatin

Pemetrexed

Gemcitabine

Study Details

Brief summary:

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).

Conditions

Carcinoma, Non-Small-Cell Lung

Study ID

NCT06623422

Start date

Oct 21, 2024

Status verified date

Aug, 2026

Completion date

Jan 26, 2038

Anticipated

Primary completion date

May 16, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 clinical 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 small cell lung cancer (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

Enrollment

680 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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).

Interventions

Pembrolizumab

IV Infusion

Cisplatin

IV infusion

Carboplatin

IV infusion

Pemetrexed

IV infusion

Gemcitabine

IV infusion

Paclitaxel

IV infusion

Intismeran autogene

IM injection

Placebo

IM injection

Primary outcome measure

  • Disease-Free Survival (DFS) [ Time Frame: Up to ~97 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Banner MD Anderson Cancer Center ( Site 0181)

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Study Coordinator

480-256-6444

The University of Arizona Cancer Center - North Campus ( Site 0163)

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Study Coordinator

520-694-2873

Providence St. Jude Medical Center ( Site 0106)

Recruiting

Fullerton, California, United States, 92835

Contacts

Study Coordinator

714-446-5900

VA Long Beach Healthcare System ( Site 0199)

Recruiting

Long Beach, California, United States, 90822

Contacts

Study Coordinator

562-826-8000

USC Norris Comprehensive Cancer Center ( Site 0205)

Recruiting

Los Angeles, California, United States, 90033

Contacts

Study Coordinator

323-865-3000

UCLA Jonsson Comprehensive Cancer Center ( Site 0135)

Recruiting

Los Angeles, California, United States, 90404

Contacts

Study Coordinator

310-825-5268

UCSF Medical Center at Mission Bay ( Site 0178)

Recruiting

San Francisco, California, United States, 94158

Contacts

Study Coordinator

877-827-3222

University of Colorado Anschutz Medical Campus ( Site 0151)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

303-724-9690

UCHealth Memorial Hospital Central ( Site 0125)

Recruiting

Colorado Springs, Colorado, United States, 80909

Contacts

Study Coordinator

719-365-5000

Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)

Recruiting

Greeley, Colorado, United States, 80631

Contacts

Study Coordinator

970-810-3894

Centura Health - St. Anthony North Health Campus ( Site 0189)

Recruiting

Westminster, Colorado, United States, 80023

Contacts

Study Coordinator

720-627-4840

Yale University School of Medicine ( Site 0201)

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Study Coordinator

203-785-7564

Eastern CT Hematology & Oncology Associates ( Site 0202)

Recruiting

Norwich, Connecticut, United States, 06360

Contacts

Study Coordinator

860-886-8362

The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

Study Coordinator

954-771-0692

Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)

Recruiting

Miami, Florida, United States, 33176

Contacts

Study Coordinator

786-596-2000

Beacon Cancer Care ( Site 0127)

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Study Coordinator

208-755-2804

The University of Chicago Medical Center ( Site 0118)

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Study Coordinator

773-702-2984

Franciscan Health ( Site 0219)

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Study Coordinator

317-528-7060

Maryland Oncology Hematology (MOH) ( Site 8102)

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Study Coordinator

570-808-4772

Massachusetts General Hospital ( Site 0136)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Study Coordinator

617-724-4000

Dana Farber Cancer Hospital ( Site 0155)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-632-3000

Roswell Park Cancer Institute ( Site 0184)

Recruiting

Buffalo, New York, United States, 14263

Contacts

Study Coordinator

716-845-3167

Hematology-Oncology Associates of CNY ( Site 0164)

Recruiting

East Syracuse, New York, United States, 13057

Contacts

Study Coordinator

315-472-7504

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)

Recruiting

New York, New York, United States, 10011

Contacts

Study Coordinator

202-207-2510

Icahn School of Medicine at Mount Sinai ( Site 0116)

Recruiting

New York, New York, United States, 10029

Contacts

Study Coordinator

212-523-5559

Memorial Sloan Kettering Cancer Center ( Site 0137)

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

212-639-2000

SUNY Upstate Cancer Center ( Site 0140)

Recruiting

Syracuse, New York, United States, 13210

Contacts

Study Coordinator

315-464-8237

Montefiore Medical Center ( Site 0160)

Recruiting

The Bronx, New York, United States, 10461

Contacts

Study Coordinator

718-405-8404

Westchester Medical Center ( Site 0196)

Recruiting

Valhalla, New York, United States, 10595

Contacts

Study Coordinator

914-493-7000

Novant Health Weisiger Cancer Insititute ( Site 0266)

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Study Coordinator

980-302-6000

Novant Health Forsyth Medical Center ( Site 0166)

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Study Coordinator

336-718-5000

University of Cincinnati Medical Center ( Site 0119)

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Study Coordinator

513-558-2119

Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217)

Recruiting

Corvallis, Oregon, United States, 97330

Contacts

Study Coordinator

541-768-4950

St. Lukes Hospital and Health Network ( Site 0186)

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Study Coordinator

484-526-7952

Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315)

Recruiting

Chattanooga, Tennessee, United States, 37403

Contacts

Study Coordinator

615-961-9469

Thompson Cancer Survival Center ( Site 0168)

Recruiting

Knoxville, Tennessee, United States, 37916

Contacts

Study Coordinator

865-331-1720

Elliston Place Medical Oncology & Hematology ( Site 0215)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-961-9469

Texas Oncology - DFW ( Site 8103)

Recruiting

Dallas, Texas, United States, 75246

Contacts

Study Coordinator

214-370-1987

UT Southwestern Medical Center ( Site 0190)

Recruiting

Dallas, Texas, United States, 75390

Contacts

Study Coordinator

214-648-3111

Houston Methodist Cancer Center ( Site 0191)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-363-8890

MD Anderson Cancer Center ( Site 0150)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-792-6363

Memorial Hermann Cancer Center ( Site 0172)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-704-3961

Michael E. DeBakey VA Medical Center ( Site 0197)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-873-200

O'Quinn Medical Tower at McNair Campus ( Site 0131)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

832-957-6500

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)

Recruiting

Tyler, Texas, United States, 75701

Contacts

Study Coordinator

903-592-6152

Virginia Cancer Specialists ( Site 0167)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

571-350-8400

Virginia Oncology Associates (VOA) ( Site 8101)

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Study Coordinator

757-466-8683

VCU Health Adult Outpatient Pavillion ( Site 0193)

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Study Coordinator

804-828-7999

Swedish Cancer Institute ( Site 0143)

Recruiting

Seattle, Washington, United States, 98104

Contacts

Study Coordinator

855-922-6237

St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192)

Recruiting

Silverdale, Washington, United States, 98383

Contacts

Study Coordinator

564-240-3100

Queen Elizabeth II Health Sciences Centre ( Site 1101)

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Study Coordinator

9024738317

Hamilton Health Sciences - Juravinski Site ( Site 1104)

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Study Coordinator

9053879495

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Study Coordinator

6135496666

Lakeridge Health ( Site 1107)

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Contacts

Study Coordinator

905-576-8711x32802

Sunnybrook Research Institute ( Site 1106)

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Study Coordinator

4164806100

McGill University Health Centre ( Site 1103)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

5149341934

IUCPQ ( Site 1112)

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Study Coordinator

4186568711

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Programmed Cell Death-1 (PD1, PD-1)
  • Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
  • Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
  • Individualized neoantigen therapy (INT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-27.