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 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
- 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 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). |
|
Recruiting Locations
Gilbert, Arizona 85234
Study Coordinator
480-256-6444
Tucson, Arizona 85719
Study Coordinator
520-694-2873
Fullerton, California 92835
Study Coordinator
714-446-5900
Long Beach, California 90822
Study Coordinator
562-826-8000
Los Angeles, California 90033
Study Coordinator
323-865-3000
San Francisco, California 94158
Study Coordinator
877-827-3222
Aurora, Colorado 80045
Study Coordinator
303-724-9690
Colorado Springs, Colorado 80909
Study Coordinator
719-365-5000
Greeley, Colorado 80631
Study Coordinator
970-810-3894
Westminster, Colorado 80023
Study Coordinator
720-627-4840
New Haven, Connecticut 06510
Study Coordinator
203-785-7564
Norwich, Connecticut 06360
Study Coordinator
860-886-8362
Fort Lauderdale, Florida 33316
Study Coordinator
954-771-0692
Miami, Florida 33176
Study Coordinator
786-596-2000
Post Falls, Idaho 83854
Study Coordinator
208-755-2804
Chicago, Illinois 60637
Study Coordinator
773-702-2984
Rockville, Maryland 20850
Study Coordinator
570-808-4772
Boston, Massachusetts 02114
Study Coordinator
617-724-4000
Boston, Massachusetts 02215
Study Coordinator
617-632-3000
Columbia, Missouri 65212
Study Coordinator
573-882-7440
Osage Beach, Missouri 65065
Study Coordinator
573-302-2772
Buffalo, New York 14263
Study Coordinator
716-845-3167
East Syracuse, New York 13057
Study Coordinator
315-472-7504
New York, New York 10011
Study Coordinator
202-207-2510
New York, New York 10029
Study Coordinator
212-523-5559
New York, New York 10065
Study Coordinator
212-639-2000
Syracuse, New York 13210
Study Coordinator
315-464-8237
The Bronx, New York 10461
Study Coordinator
718-405-8404
Valhalla, New York 10595
Study Coordinator
914-493-7000
Charlotte, North Carolina 28204
Study Coordinator
980-302-6000
Winston-Salem, North Carolina 27103
Study Coordinator
336-718-5000
Cincinnati, Ohio 45219
Study Coordinator
513-558-2119
Bethlehem, Pennsylvania 18015
Study Coordinator
484-526-7952
Knoxville, Tennessee 37916
Study Coordinator
865-331-1720
Nashville, Tennessee 37203
Study Coordinator
615-961-9469
Dallas, Texas 75246
Study Coordinator
214-370-1987
Dallas, Texas 75390
Study Coordinator
903-592-6152
Houston, Texas 77030
Study Coordinator
713-363-8890
Houston, Texas 77030
Study Coordinator
713-792-6363
Houston, Texas 77030
Study Coordinator
713-704-3961
Houston, Texas 77030
Study Coordinator
713-873-200
Houston, Texas 77030
Study Coordinator
832-957-6500
Tyler, Texas 75701
Study Coordinator
903-592-6152
Fairfax, Virginia 22031
Study Coordinator
571-350-8400
Norfolk, Virginia 23502
Study Coordinator
757-466-8683
Richmond, Virginia 23219
Study Coordinator
804-828-7999
Seattle, Washington 98104
Study Coordinator
855-922-6237
Silverdale, Washington 98383
Study Coordinator
564-240-3100
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC