Non-small Cell Lung Cancer
Conditions
Brief summary
Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery. People with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer. The main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.
Interventions
BIOLOGICALIntismeran
IM injection
BIOLOGICALPembrolizumab coformulated with berahyaluronidase alfa
SC injection
OTHERPlacebo
IM injection
Sponsors
Merck Sharp & Dohme LLC
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Arm A - Open Label Arms B and C - Double Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size \>2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology * Has undergone a complete surgical resection of the primary NSCLC * Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC * Has provided a tissue sample from recent surgery along with the required blood sample * Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C | Up to approximately 98 months | DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS as Assessed by BICR | Up to approximately 98 months | DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first. |
| Distant Metastasis-Free Survival (DMFS) | Up to approximately 111 months | DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis by BICR or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes. |
| Overall Survival (OS) | Up to approximately 123 months | OS is defined as the time from randomization to death due to any cause. |
| Number Participants Who Experience an Adverse Events (AE) | Up to approximately 144 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. The number of participants who experience an AE will be reported. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 144 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. The number of participants who discontinue study intervention due to an AE will be reported. |
| Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score | Baseline and up to approximately 36 months | EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented. |
| Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score | Baseline and up to approximately 36 months | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented. |
| Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score | Baseline and up to approximately 36 months | EORTC QLQ-C30 is a questionnaire to assess the overall QoL 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. A higher score indicates 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. |
Countries
Australia, Brazil, Canada, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed