On September 28, 2026 Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the first patient has been dosed in SPARROW NCT07831824, a Phase 2/3 registrational trial evaluating LNTH-2401 (68Ga-DOTA-RM2). LNTH-2401 is an investigational gallium-68-labeled positron emission tomography (PET) imaging agent that targets the gastrin-releasing peptide receptor (GRPR), a biomarker that is highly expressed in many prostate cancers.
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SPARROW is an open-label, non-randomized, multicenter Phase 2/3 study that includes an initial Phase 2 dose optimization period followed by a Phase 3 diagnostic performance period. The Phase 3 co-primary endpoints are sensitivity and specificity of LNTH-2401 PET/CT imaging compared with histopathology. The Phase 3 portion of the trial is expected to enroll approximately 400 participants and will evaluate diagnostic performance, safety and tolerability.
"Accurate characterization of disease remains critically important in prostate cancer, particularly as treatment decisions become increasingly personalized," said Harshad R. Kulkarni, MD, Chief Medical Advisor at BAMF Health and a principal investigator in the SPARROW study. "We are pleased to have dosed the first patient at BAMF Health, where our integrated molecular imaging, radiopharmacy and clinical trials infrastructure supports the evaluation of emerging radiopharmaceutical technologies. GRPR represents a promising and biologically distinct target in prostate cancer, and SPARROW will help define the role GRPR-targeted PET may play in disease detection and characterization."
GRPR is highly expressed in many primary prostate cancers and has a biologic expression pattern distinct from PSMA. Emerging research suggests GRPR-targeted imaging may provide additional insight in certain tumors that are not optimally characterized using PSMA-directed approaches alone.1
"Dosing the first patient in SPARROW represents a significant step forward for our pipeline and underscores our commitment to advancing innovative radiopharmaceuticals across the prostate cancer care continuum," said Ludger Dinkelborg, Head of Research and Development at Lantheus. "As the leader in prostate cancer PSMA PET imaging, LNTH-2401 has the potential to expand our understanding of prostate cancer biology through a complementary imaging target. This program reflects our broader strategy to build a focused pipeline of differentiated radiodiagnostics that may support more informed clinical decision-making."
About SPARROW
SPARROW is an open-label, non-randomized, multicenter Phase 2/3 clinical trial evaluating investigational 68Ga-LNTH-2401 PET/CT imaging in prostate cancer. The study consists of a Phase 2 dose optimization period followed by a Phase 3 diagnostic performance period.
During Phase 2, up to 12 imaging-evaluable participants with newly diagnosed or biochemically recurrent prostate cancer will receive 68Ga-LNTH-2401 PET/CT imaging to determine the optimal administered activity and imaging time window. Phase 2 will also assess biodistribution, radiation dosimetry, image quality, safety and tolerability. Data from participants with GRPR-positive lesions are expected to support selection of the administered activity and imaging time window for Phase 3.
During Phase 3, approximately 400 participants with newly diagnosed prostate cancer who are at least high risk or have suspected metastatic disease and are eligible for radical prostatectomy with pelvic lymph node dissection will undergo 68Ga-LNTH-2401 PET/CT imaging using the optimized imaging parameters selected during Phase 2.
The Phase 3 co-primary endpoints are participant-level sensitivity and specificity of 68Ga-LNTH-2401 PET/CT imaging compared with histopathology. Secondary diagnostic performance assessments include positive predictive value (PPV), negative predictive value (NPV), regional detection performance, comparative summaries versus conventional imaging and/or PSMA PET imaging where applicable, and assessment of inter-reader and intra-reader agreement. Safety and tolerability will also be evaluated.
(Press release, Lantheus, SEP 28, 2026, View Source [SID1234671109])