680 Participants Needed

V940 + Pembrolizumab for Non-Small Cell Lung Cancer

Recruiting at 139 trial locations
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Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Pembrolizumab
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain cancer treatments or vaccines recently. It's best to discuss your current medications with the trial team.

Is the combination of V940 and Pembrolizumab safe for humans?

Pembrolizumab (also known as Keytruda) has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, cough, nausea, and more serious immune-related issues like pneumonitis (lung inflammation). While specific safety data for the combination with V940 is not detailed, pembrolizumab's safety profile is well-documented in other conditions.12345

What makes the drug pembrolizumab unique for treating non-small cell lung cancer?

Pembrolizumab is unique because it is an immunotherapy drug that works by blocking the PD-1 pathway, helping the immune system attack cancer cells more effectively. It is used for patients whose tumors express PD-L1, and it has shown significant improvements in survival compared to traditional chemotherapy.12567

What data supports the effectiveness of the drug V940 + Pembrolizumab for Non-Small Cell Lung Cancer?

Research shows that pembrolizumab, a part of this drug combination, has been effective in improving outcomes for patients with advanced non-small cell lung cancer, especially when the cancer cells have high levels of PD-L1, a protein that helps tumors avoid the immune system.12678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with resectable Stage II-III non-small cell lung cancer (NSCLC) who haven't had prior treatments and whose tumors didn't fully respond to initial therapy before surgery. They must be in good physical condition, not need EGFR-targeted primary therapy, and can have controlled hepatitis B or C or HIV.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.
My cancer does not have EGFR mutations, so I don't need EGFR-targeted therapy.
I have HIV and it is well controlled with medication.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive pembrolizumab and chemotherapy for up to 4 cycles before surgery

12 weeks
4 visits (in-person)

Surgical Resection

Participants undergo surgical resection of the tumor

1 week
1 visit (in-person)

Adjuvant Treatment

Participants receive pembrolizumab and V940 or placebo for up to 7 cycles post-surgery

42 weeks
7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

97 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • V940
Trial Overview The study tests if V940 combined with pembrolizumab extends the time patients remain cancer-free post-surgery compared to a placebo plus pembrolizumab. It's for NSCLC patients whose cancer persisted after neoadjuvant treatment and surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + Intismeran autogeneExperimental Treatment7 Interventions
Group II: Pembrolizumab + PlaceboActive Control7 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

ModernaTX, Inc.

Industry Sponsor

Trials
127
Recruited
66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
A 68-year-old patient with stage IV lung adenocarcinoma showed an unexpected positive response to paclitaxel after failing treatment with pembrolizumab, an anti-PD-1 immunotherapy.
The patient experienced a response duration of over fourteen months with paclitaxel, suggesting that combining or sequencing chemotherapy with immunotherapy may enhance treatment effectiveness in certain cases.
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer].Zapata, E., Mennecier, B., Leduc, C., et al.[2017]

Citations

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]
Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer. [2022]
Pembrolizumab Shows Promise for NSCLC. [2015]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
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