INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis

Purpose

This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer.

Eligibility

  • Ages: 18 and older
  • Sexes: All
  • Accepts healthy volunteers?: No
For additional eligibility criteria, please contact the study team.

Procedures

Patients are randomized to 1 of 3 arms. After completion of study treatment, patients are followed up for 5 years.

Contact the study team

Additional eligibility criteria and study procedure details can be explained by the study team. Please call or email:

Danielle Geckler
Phone: 352.265.0680 ext. 87669
Email: d.geckler@ufl.edu

Age

18 to 65
65 and over

Gender

Male
Female

Keywords

Non-squamous non-small cell lung cancer, Carboplatin, Pembrolizumab, Pemetrexed

Principal Investigator

Frederic Kaye, MD

Department

Oncology

Contact Information

d.geckler@ufl.edu

352.265.0680 ext. 87669


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