A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Purpose
The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
Condition
- Non-small Cell Lung Cancer
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 undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines. - Has no evidence of disease before randomization. - Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy. - No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab. - 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. - Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
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. - HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. - Received prior neoadjuvant therapy for their current NSCLC diagnosis. - Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis. - Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. - Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. - Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. - Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. - Known additional malignancy that is progressing or has required active treatment within the past 5 years. - Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed. - History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. - Active infection requiring systemic therapy.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intismeran autogene + Pembrolizumab |
Participants will receive 1 mg of intismeran autogene via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner. |
|
|
Active Comparator Placebo + Pembrolizumab |
Participants will receive intismeran autogene-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner. |
|
Recruiting Locations
Anchorage, Alaska 99508
Study Coordinator
907-257-9851
Tucson, Arizona 85719
Study Coordinator
520-694-2873
Los Angeles, California 90095
Study Coordinator
310-267-9099
Newport Beach, California 92663
Study Coordinator
949-764-4060
Newport Beach, California 92663
Study Coordinator
949-764-4060
Orange, California 92868
Study Coordinator
714-541-6622
Orange, California 92868
Study Coordinator
818-426-7690
Washington D.C., District of Columbia 20037
Study Coordinator
202-741-2210
Jacksonville, Florida 32224
Study Coordinator
855-776-0015
Miami, Florida 33176
Study Coordinator
786-596-2000
Orange City, Florida 32763
Study Coordinator
386-538-3169
Orlando, Florida 32804
Study Coordinator
407-303-2024
Tampa, Florida 33612
Study Coordinator
813-580-7073
Newnan, Georgia 30265
Study Coordinator
770-400-6305
Peoria, Illinois 61615
Study Coordinator
309-243-3605
Iowa City, Iowa 52242
Study Coordinator
319-356-1616
Edgewood, Kentucky 41017
Study Coordinator
859-301-4737
Louisville, Kentucky 40202
Study Coordinator
502-562-3919
Baton Rouge, Louisiana 70805
Study Coordinator
225-358-2312
Baton Rouge, Louisiana 70808
Study Coordinator
225-358-2312
Ann Arbor, Michigan 48109
Study Coordinator
800-865-1125
Grand Rapids, Michigan 49503
Study Coordinator
616-954-9800
Lincoln, Nebraska 68506
Study Coordinator
284-564-1485
Basking Ridge, New Jersey 07920
Study Coordinator
646-888-4409
Hackensack, New Jersey 07601
Study Coordinator
551-996-5855
Middletown, New Jersey 07748
Study Coordinator
646-888-4409
Montvale, New Jersey 07645
Study Coordinator
646-888-4409
Morristown, New Jersey 07960
Study Coordinator
973-971-6283
Albany, New York 12206
Study Coordinator
518-489-0044
Commack, New York 11725
Study Coordinator
646-888-4409
Harrison, New York 10604
Study Coordinator
646-888-4409
Mineola, New York 11501
Study Coordinator
409-543-5553
New York, New York 10011
Study Coordinator
888-577-8839
New York, New York 10016
Study Coordinator
409-543-5553
New York, New York 10029
Study Coordinator
888-577-8839
New York, New York 10065
Study Coordinator
212-639-2000
The Bronx, New York 10461
Study Coordinator
718-405-8404
Uniondale, New York 11553
Study Coordinator
646-888-4409
Charlotte, North Carolina 28204
Study Coordinator
980-302-6000
Winston-Salem, North Carolina 27103
Study Coordinator
336-277-8800
Fargo, North Dakota 58102
Study Coordinator
701-234-6161
Grand Forks, North Dakota 58201
Study Coordinator
701-780-5400
Cleveland, Ohio 44106
Study Coordinator
800-641-2422
Columbus, Ohio 43210
Study Coordinator
614-366-6174
Corvallis, Oregon 97330
Study Coordinator
541-768-7169
Philadelphia, Pennsylvania 19107
Study Coordinator
215-600-9151
Charleston, South Carolina 29425
Study Coordinator
843-792-9300
Chattanooga, Tennessee 37421
Study Coordinator
423-698-1844
Knoxville, Tennessee 37916
Study Coordinator
865-331-1812
Memphis, Tennessee 38120
Study Coordinator
901-226-1485
Nashville, Tennessee 37203
Study Coordinator
731-267-3491
Nashville, Tennessee 37203
Study Coordinator
615-329-7640
Dallas, Texas 75390
Study Coordinator
214-648-3111
Fairfax, Virginia 22031
Study Coordinator
571-472-4724
Fairfax, Virginia 22031
Study Coordinator
730-280-5390
Seattle, Washington 98104
Study Coordinator
206-386-2323
Seattle, Washington 98109
Study Coordinator
206-606-4801
Huntington, West Virginia 25701
Study Coordinator
304-399-6521
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC