Clinical trial for Carcinoma, Non-Small-Cell Lung
Official title A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
ClinicalTrials.gov ID: NCT06623422
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational biological medicine being studied as a potential treatment after surgery for non‑small‑cell lung cancer. Pembrolizumab is designed to block the PD‑1 protein on immune cells, helping the immune system recognize and attack cancer cells.
Also referred to as KEYTRUDA®, MK-3475.
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
- This study is testing whether adding a new vaccine to a cancer drug helps prevent cancer from coming back. It looks at people who had surgery for non-small cell lung cancer.
- Who it's for
- You may be able to join if you have non-small cell lung cancer and had surgery. Your cancer did not fully shrink before the surgery.
- What's involved
- You would get a new vaccine called intismeran autogene. You would also get a drug called pembrolizumab. Some people get a pretend shot instead of the vaccine.
- Time commitment
- The study lasts for a set time after your surgery. You will need to come in for check-ups and tests.
- 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
- Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB...
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
- Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed...
- Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of...
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
You likely can't join if
- Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell...
- Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
- Received prior neoadjuvant therapy for their current NSCLC diagnosis
- Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand...
- Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
- Received prior treatment with a cancer vaccine
See the full eligibility criteria
- Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on...
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
- Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
- Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R])
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral 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...
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- 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, or a pancoast tumor
- Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
- Received prior neoadjuvant therapy for their current NSCLC diagnosis
- Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or...
- Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
- Received prior treatment with a cancer vaccine
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Tucson, Arizona, United States
- Fullerton, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Greeley, Colorado, United States
- Westminster, Colorado, United States
- New Haven, Connecticut, United States
- Norwich, Connecticut, United States
- Fort Lauderdale, Florida, United States
- Miami, Florida, United States
- Post Falls, Idaho, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- Rockville, Maryland, United States
- Boston, Massachusetts, United States
+ 178 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, but 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?
This study is enrolling now at Gilbert, Arizona, United States; Tucson, Arizona, United States; Fullerton, California, United States; Long Beach, California, United States; Los Angeles, California, United States; San Francisco, California, United States and 192 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.