Florida Cancer Specialists & Research Institute Phase 3 Trial Demonstrates Initial Clinical Benefit of Novel Immunotherapy For Advanced Non-Small Cell Lung Cancer

PRESERVE-003 Stage 1 evaluation of gotistobart published in Nature Medicine

FORT MYERS, Fla., April 7, 2026 /PRNewswire/ -- Key findings from stage 1 of the PRESERVE-003 Phase 3 clinical trial conducted with participation from Florida Cancer Specialists & Research Institute, LLC (FCS) have shown that gotistobart, a novel CTLA-4 checkpoint-targeting immunotherapy, may offer improved effectiveness with fewer side effects in patients with metastatic non-small cell lung cancer (NSCLC). The global PRSERVE-003 trial is a multi-year, groundbreaking study evaluating gotistobart against the chemotherapy drug docetaxel in people with squamous NSCLC (sqNSCLC) whose disease has worsened after standard immunotherapy and chemotherapy.

FCS principal investigators Adewale Fawole, MD and Fadi Kayali, MD, with specialized expertise in lung cancer, are co-authors of the study abstract published in Nature Medicine.  

Gustavo A. Fonseca, MD, FACP, FCS director of research and clinical trials, said, "Lung cancer remains the leading cause of cancer deaths worldwide and treatment options have historically been limited. FCS clinical research is contributing to discoveries that are revolutionizing the treatment of these and other advanced cancers."

Patients with metastatic NSCLC were randomized into stage 1 of the study conducted from June 2023 to September 2024 in study centers in the U.S., Australia, China, Korea and the UK. Stage 1 aimed "to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rate and duration of response) and safety of gotistobart compared to docetaxel." 

The trial has moved forward into its pivotal later stage where the findings will be confirmed in a larger population of patients with sqNSCLC. The authors note: "The primary endpoint of PRESERVE-003 is overall survival (OS), and secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and safety."

FCS provides ongoing access to more than 180 clinical trials within 29 FCS clinics statewide and early-phase Drug Development Units (DDUs) located in Sarasota and Central Florida. Research conducted at FCS is made possible in partnership with Sarah Cannon Research Institute, one of the world's leading oncology research organizations conducting community-based clinical trials.

View the abstract:  Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial

About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com)
For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program.

FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. Through its robust clinical research program with Sarah Cannon Research Institute (SCRI) and a suite of independent site management programs, with advanced clinical trial matching technology, FCS offers patients innovative therapies close to home. Each year, FCS conducts more than 180 active clinical trials that directly elevate patient care and accelerate progress in oncology. Many of the cancer drugs approved by the FDA in the U.S over the past decade were accessible to patients at FCS through clinical trial participation before receiving approval.

Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes.

SOURCE Florida Cancer Specialists & Research Institute