Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

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

NCT06077760 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • BIOLOGICAL Pembrolizumab
  • OTHER Placebo
  • BIOLOGICAL Intismeran autogene

Study Locations (20)

California

  • UCLA Clinical & Translational Research Center (CTRC) ( Site 0059) — Los Angeles
  • Hoag Memorial Hospital Presbyterian ( Site 4042) — Newport Beach
  • Hoag Memorial Hospital Presbyterian ( Site 4048) — Newport Beach
  • St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074) — Orange
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030) — Orange

Florida

  • Mayo Clinic Florida ( Site 4043) — Jacksonville
  • Miami Cancer Institute at Baptist Health, Inc. ( Site 4047) — Miami
  • Mid Florida Hematology and Oncology Center ( Site 0014) — Orange City
  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013) — Orlando
  • Moffitt Cancer Center ( Site 0078) — Tampa

Arizona

  • The University of Arizona Cancer Center - North Campus ( Site 0071) — Tucson
  • YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020) — Yuma

Georgia

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012) — Marietta
  • Southeastern Regional Medical Center ( Site 0098) — Newnan

Alaska

  • Alaska Oncology and Hematology ( Site 0039) — Anchorage

Colorado

  • UCHealth Memorial Hospital-Heme Onc ( Site 0052) — Colorado Springs

Idaho

  • Beacon Cancer Care ( Site 0044) — Post Falls

Illinois

  • Illinois Cancer Care ( Site 7003) — Peoria

Trial Details

FieldValue
Enrollment Target 868 participants
Start Date 2023-12-06
Est. Completion 2035-12-21
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06077760

The ClinicalTrials.gov registry entry for NCT06077760 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 868 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06077760 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06077760 about?

NCT06077760 is a clinical study titled "A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)". 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 in...

What is the current status of trial NCT06077760?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 868 participants. The study started on 2023-12-06. Estimated completion is 2035-12-21.

What conditions does trial NCT06077760 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06077760?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), Intismeran autogene (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06077760?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06077760 being conducted?

This trial has 20 study locations across Alaska, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial