History of Changes for Study: NCT06077760

A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

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Study Record Versions

Version	Submitted Date	Changes
1	October 5, 2023	None (earliest Version on record)
2	October 18, 2023	References and Study Status
3	November 7, 2023	Recruitment Status, Study Status and Contacts/Locations
4	December 18, 2023	Study Status and Contacts/Locations
5	January 18, 2024	Study Status and Contacts/Locations
6	February 22, 2024	Study Status and Contacts/Locations
7	March 6, 2024	Study Status and Contacts/Locations
8	March 13, 2024	Contacts/Locations and Study Status
9	April 4, 2024	Study Status and Contacts/Locations
10	April 10, 2024	Contacts/Locations and Study Status
11	April 17, 2024	Contacts/Locations and Study Status
12	May 10, 2024	Study Status, Study Identification, Contacts/Locations, Eligibility and Arms and Interventions
13	May 16, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	V940-002
Brief Title:	A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Official Title:	A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer
Secondary IDs:	2023-504923-20 [Registry Identifier: EU CT] U1111-1290-3969 [UTN]

Study Status


Record Verification:	October 2023
Overall Status:	Not yet recruiting
Study Start:	November 23, 2023
Primary Completion:	June 25, 2030 [Anticipated]
Study Completion:	December 21, 2035 [Anticipated]

First Submitted:	October 5, 2023
First Submitted that Met QC Criteria:	October 5, 2023
First Posted:	October 11, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	October 5, 2023
Last Update Posted:	October 11, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Merck Sharp & Dohme LLC
Responsible Party:	Sponsor
Collaborators:	ModernaTX, Inc.

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of completely resected (R0) Stage II, IIIA, IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Detailed Description:

Conditions


Conditions:	Non-small Cell Lung Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	868 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: V940 + Pembrolizumab Participants will receive 1 mg of V940 via intramuscular (IM) injection once every 3 weeks for up to 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.	Biological: V940 IM injection Other Names: mRNA-4157 Biological: Pembrolizumab IV infusion Other Names: MK-3475 KEYTRUDA®
Active Comparator: Placebo + Pembrolizumab Participants will receive V940-matched placebo via IM injection once every 3 weeks for up to 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.	Biological: Pembrolizumab IV infusion Other Names: MK-3475 KEYTRUDA® Placebo IM injection

Outcome Measures


Primary Outcome Measures:
1.	Disease- Free Survival (DFS) [ Time Frame: Up to ~78 months ] DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.
Secondary Outcome Measures:
1.	Overall Survival (OS) [ Time Frame: Up to ~12 years ] OS is defined as the time from randomization to death due to any cause.
2.	Distant Metastasis-Free Survival (DMFS) [ Time Frame: Up to ~12 years ] DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by the investigator, or death due to any cause, whichever occurs first.
3.	Lung Cancer Specific Survival (LCSS) [ Time Frame: Up to ~12 years ] LCSS is defined as the time from randomization to death due to lung cancer.
4.	Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score [ Time Frame: Baseline and up to ~12 years ] The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
5.	Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 [ Time Frame: Baseline and up to ~12 years ] The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of physical functioning. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
6.	Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 [ Time Frame: Baseline and up to ~12 years ] The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of role functioning. The change from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented.
7.	Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30 [ Time Frame: Baseline and up to ~12 years ] The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of dyspnea. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented.
8.	Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24 [ Time Frame: Baseline and up to ~12 years ] The EORTC QLQ-LC24 is a lung cancer specific health-related quality of life questionnaire. Participant responses to questions about coughing will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates more coughing. The change from baseline in coughing (EORTC QLQ-LC24 Items 31 and 52) combined score will be presented.
9.	Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24 [ Time Frame: Baseline and up to ~12 years ] The EORTC QLQ-LC24 is a lung cancer specific health-related quality of life questionnaire. Participant responses to the question "Have you had pain in your chest?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. The change from baseline in chest pain (EORTC QLQ-LC24 Item 40) score will be presented.
10.	Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to ~15 months ] An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
11.	Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to ~12 months ] An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Has surgically resected and histologically confirmed diagnosis of Stage II, IIIA, IIIB (N2) squamous or nonsquamous NSCLC as per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines. Has no evidence of disease at the time of providing documented consent for the main study. 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.

Contacts/Locations


Study Officials:	Medical Director Study Director Merck Sharp & Dohme LLC
Locations:

IPDSharing


Plan to Share IPD:	Yes http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL: http://engagezone.msd.com/ds_documentation.php

References


Citations:
Links:	URL: http://www.merckclinicaltrials.com Description: Merck Clinical Trials Information
Available IPD/Information: