RecruitingPhase 2

A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests intismeran autogene (V940) with pembrolizumab and chemotherapy for squamous non-small cell lung cancer that has spread and has not yet been treated with whole-body medicines. V940 is designed to help the immune system attack a person's specific cancer. Researchers will compare it with a placebo, which has no study treatment, to see if people live longer and go longer without their cancer growing or spreading.

Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage 4 squamous non-small cell lung cancer confirmed by a tissue or cell test, with no small cell cancer mixed in.
  • Have cancer that can be measured on scans.
  • Provide a tissue sample taken when or after the cancer was found to have spread, from an area not treated with radiation.
  • Side effects from past cancer treatment must be mild or gone. Some hormone problems and moderate nerve damage are allowed.
  • If you have HIV, it must be well controlled with HIV medicines.
  • If you have hepatitis B, take antiviral medicine for at least 4 weeks and have no virus detected before study group assignment.
  • If you have had hepatitis C, have no virus detected and finish treatment to cure it at least 4 weeks before study group assignment.
  • Be fully active or able to do light work, have organs that work well enough, and be expected to live at least 3 months.

Who can't join

  • Past treatment with a cancer vaccine or whole-body cancer medicines for lung cancer that has spread.
  • Past treatment with certain immune-based cancer medicines. Some earlier treatment for lung cancer that had not spread is allowed if it ended at least 12 months before the cancer spread.
  • Radiation within 2 weeks before study treatment, radiation side effects needing steroids, or lung radiation above 30 gray (a radiation dose measure) within 6 months.
  • A live vaccine within 30 days, or an experimental medicine or device within 4 weeks before study treatment.
  • A weak immune system, recent medicines that suppress it, or an autoimmune disease—where the body attacks itself—that needed whole-body treatment in the past 2 years.
  • Another cancer that is growing or needed treatment within 3 years, or active cancer spread to the brain, spinal cord, or their lining.
  • A severe allergy to study medicines or their ingredients, current lung inflammation, past lung inflammation needing steroids, or an active infection needing whole-body treatment.
  • A past stem cell or organ transplant, incomplete recovery or ongoing problems from major surgery, or HIV with a history of Kaposi's sarcoma or Multicentric Castleman's disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Inclusion Criteria include, but are not limited to: * Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted. * Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology * Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated * Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * Hepatitis B surface antigen (HBsAg) positive participants 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. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization * Has a life expectancy of at least 3 months * Has adequate organ function Exclusion Criteria: Exclusion Criteria include, but are not limited to: * Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV) * Has received prior systemic anticancer therapy for their metastatic NSCLC * Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Has received radiation therapy to the lung that is \>30 gray within 6 months of start of study intervention * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has a 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 dose of study intervention * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients * Has active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has a history of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications

Study sites (11)

FL

MI

MO

NJ

NY

OH

OR

  • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025) · Corvallis, OR 97330Study Coordinator · Study contact · 541-768-4950More trials in Corvallis

TN

  • Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000) · Nashville, TN 37203Study Coordinator · Study contact · 615-961-9469More trials in Nashville

TX

VA

WA