C34 Malignant neoplasm of bronchus and lung Malignant neoplasm of bronchus and lung
Conditions
Interventions
V940 as 1 mg/ml injection. 1 mg will be administered intramuscularly every 3 weeks for 9 cycles. And Pembrolizumab as 25 mg/ml Injection. 400 mg will be administered by intravenous infusion every 6 we
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria 1 through 14 apply to screening for both the Neoadjuvant and Adjuvant Phases: Type of Participant and Disease Characteristics The participant must have a histologically/cytologically confirmed diagnosis of previously untreated (with the exception of participants enrolling after the specified neoadjuvant treatment and surgery) and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC (AJCC 8th Edition) (See Appendix 9 of protocol). Has an ECOG performance status of 0 or 1 within 7 days before the first dose of study intervention for both study phases. Be able to undergo protocol therapy, including necessary surgery as determined by the investigator. Note: Participants with resectable Stages II, IIIA, or IIIB (N2) NSCLC treated before enrolling in the study with up to 4 cycles of pembrolizumab and SOC platinum-doublet chemotherapy up to 4 cycles (or equivalent dose of platinum-doublet chemotherapy) and had an R0 lobectomy or pneumonectomy, may enter the study if all eligibility criteria are met. Participants who have not achieved a pCR following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible. Confirmation that EGFR-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R]). Note: If participant’s tumor has a predominantly squamous histology, molecular testing for EGFR mutation is not required. Demographics Is at least 18 years of age at the time of providing the informed consent. Assigned Male Sex at Birth If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for study intervention is: • V940: 0 days (no requirement) • Pembrolizumab: 0 days (no requirement) • Chemotherapy: 95 days • Postsurgical RT, if performed: 90 days • Refrains from donating sperm PLUS either: • Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR • Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview) as detailed below: • Uses a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive method, as a condom may break or leak. Note: Participants capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use a penile/external condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate. • Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed. Assigned Female Sex at Birth A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the f
Exclusion criteria
Exclusion criteria: Participants who have not adequately recovered from major surgery or have ongoing surgical complications. Known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study. Documentation by local test report indicating presence of ALK gene rearrangements (ALK status not required and unknown or undetermined ALK status are acceptable, central testing will not be provided). Criteria 1 through 21 apply to screening for both the Neoadjuvant and Adjuvant Phases: Medical Conditions 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. Prior/Concomitant Therapy Received prior neoadjuvant therapy for their current NSCLC diagnosis, other than what is specified in this protocol. Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, 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, including another INT. 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. Administration of killed vaccines is allowed. Refer to Section 6.5 for information on COVID-19 vaccines. Prior/Concurrent Clinical Study Experience Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. Diagnostic Assessments 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 intervention. 11. Known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk earlystage prostate cancer (T1-T2a, Gleason score =6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded. Severe hypersensitivity (=Grade 3) to V940, pembrolizumab, or any of the neoadjuvant chemotherapy agents and/or any of their excipients. 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. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease. Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Note: Hepatitis B and C screening tests are not required unless: - Known history of HBV and HCV infection - As mandated by
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stratified log-rank test Estimation: Cox model stratified with Efron method for handling ties NAME OF THE RESULT: Disease-free survival (DFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to any recurrence (local, locoregional, regional, or distant), occurrence of a new primary NSCLC, or death from any cause, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| Stratified log-rank test Estimation: Cox model stratified with Efron method for handling ties NAME OF THE RESULT: Disease-free survival (DFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to any recurrence (local, locoregional, regional, or distant), occurrence of a new primary NSCLC, or death from any cause, whichever occurs first;Stratified log-rank test, stratified Cox model with Efron method for handling ties. NAME OF THE RESULT: Overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to death from any cause;Imaging and biopsy NAME OF THE RESULT: Distant metastasis-free survival (DMFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to death from any cause;Imaging and biopsy NAME OF THE RESULT: Disease-free survival after start of next line of oncologic therapy (DFS2) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to death from any cause or disease recurrence outside the urothelium, as assessed by the investigator;Imaging and biopsy NAME OF THE RESULT: Lung cancer-specific survival (LCSS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to death from any cause or disease recurrence outside the urothelium, as assessed by the investigator | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea South, Mexico, Nederland, Peru, Poland, Romania, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactNELVA GARCIA
MERCK SHARP & DOHME PERU S.R.L.
Outcome results
None listed