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Compares treatment options for Non-small Cell Lung Cancer
Official title A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
ClinicalTrials.gov ID: NCT06077760
What this study is testing
What is Intismeran autogene?
Intismeran autogene is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as mRNA-4157, V940.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main 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...
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- The main 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...
- 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...
- 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Tucson, Arizona, United States
- Yuma, Arizona, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- Colorado Springs, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Marietta, Georgia, United States
- Newnan, Georgia, United States
- Post Falls, Idaho, United States
- Peoria, Illinois, United States
- Iowa City, Iowa, United States
- Edgewood, Kentucky, United States
- Louisville, Kentucky, United States
+ 181 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Tucson, Arizona, United States; Yuma, Arizona, United States; Los Angeles, California, United States; Newport Beach, California, United States; Orange, California, United States and 195 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.