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Non-small Cell Lung Cancer (NSCLC) - Healing Genes
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Non-small Cell Lung Cancer (NSCLC)

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A Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With Non-small Cell Lung Cancer (NSCLC)


Phase 1/2

DESCRIPTION:

Doctors at research facilities in AZ, FL, NY, and WI seek patients with Non-small Cell Lung Cancer (NSCLC) to trial a therapeutic mRNA vaccine. This vaccine is an engineered type of RNA that cells can use as instructions to make proteins needed for an optimal immune response to their cancer. The study also evaluates use of the vaccine in combination with antibodies to help the immune system recognize and attack cancer cells.

Study participants will receive intradermal injections of the vaccine along with antibody treatments, which a control group will receive only the antibodies every 4 weeks. Follow up will continue for up to 15 months, with check ins at 8 and 24 weeks.


PATIENT MUST:

  • Be age 18 or older
  • Not have skin disease (e.g., psoriasis) that may prevent intradermal administration of the vaccine into the target areas
  • Have histologic confirmation of metastatic NSCLC

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Intramuscular injection of the therapy or placebo, with CELLECTRA™-5PSP electric muscle stimulation to enhance absorption of the vaccine
  3. Repeat of step (2) at 4 weeks and 12 weeks
  4. Follow up with lab and physical assessments for up to 36 weeks.

LOCATIONS & CONTACTS:

Contact: Andrew Park  |  212-450-1515  |  [email protected]

 

Study locations are participating in Gilbert, AZ, Tampa, FL, New York, NY, and Milwaukee, WI.

SPONSORS

Ludwig Institute for Cancer Research

Cancer Research Institute, New York City

Boehringer Ingelheim

MedImmune LLC

CureVac AG

PharmaJet, Inc.

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03164772

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