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Single-arm, open-label study of 177Lu-RAD204 consisting of a Phase 0 Imaging Period (Im) and a Phase 1 Treatment Period (Tr).

177Lu-RAD204 administered at Imaging (im) and Treatment (tr) doses

177Lu-RAD204

Kenneth O'Byrne, MD

Daniel Brungs, MD

Joe Cardaci, MD

This is a first-in-human, open-label study consisting of a Screening Period, an Imaging Period, and a Treatment Period in eligible non-small lung cancer patients who are positive for the biomarker PDL-1. The Screening period lasts up to 4 weeks. The Phase 0 (Imaging Period) is used to determine if patient's tumor(s) are still positive for the biomarker, as well as radiation dosimetry with low dose 177Lu-RAD204im (for a period of up to 2 weeks following the first injection of 177Lu-RAD204im), to assess the safety of the drug. Following the 2 week safety assessment, the subject is eligible to enter Phase I (Treatment Period) with gradual dose increases of 177Lu-RAD204tr. The Treatment Period lasts up to 3 cycles every 6 weeks, with additional extension to a maximum study dose interval of 12 weeks to be approved on a case-by-case basis in discussion with study Sponsor. During the Treatment Period, subjects will be assessed for both safety and treatment response using conventional images and clinical laboratory tests.

177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer

Phase 0/1 Study of the Safety and Tolerability of 177Lu-RAD204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients With Metastatic Non-small Cell Lung Cancer

Standard of care imaging may include but is not limited to 18F-FDG-PET, CT-scan and/or 99mTc-MDP-bone

Percent of the injected activity vs time for selected organs and tumors

Absorbed radiation doses of 177Lu-RAD204im in critical organs (e.g., kidneys, bone marrow)

Time-integrated activity coefficients of 177Lu-RAD204im in organs and tumor lesions

The properties, incidence, nature and severity of AEs and SAEs per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Incidence of dose-limiting toxicities (DLTs) during the first 6 weeks following 177Lu-RAD204tr injection cycle of treatment

Incidence of dose-limiting toxicities (DLTs) in the first 2 weeks following 177Lu-RAD204im injection

Objective response rates (ORR) as assessed by RECIST v1.1

Absorbed radiation doses of 177Lu-RAD204tr in critical organs (e.g., kidneys, bone marrow)

Radiopharm Theranostics, Ltd

Antineoplastic Agents

Atezolizumab

Immunomodulating Agents

Participants will receive four preoperative doses of PDL-1 inhibitor Serplulimab in adults with untreated, surgically resectable early (stage IB, II, or IIIA) NSCLC. Serplulimab (at a dose of 4.5mg per kilogram of body weight) was administered intravenously every 3 weeks, with surgery planned approximately 4 weeks after the last dose.

Serplulimab for 4.5mg/kg IV Q3W day 1,22,43,64

Serplulimab

The goal of this clinical trial is to observe the efficacy and safety of Serplulimab monotherapy as a neoadjuvant treatment for TPS ≥ 50% non-small cell lung cancer (NSCLC).

The study aims to explore new strategies for neoadjuvant treatment of resectable NSCLC patients with TPS ≥ 50%, and to identify potential prognostic biomarkers.

Participants with stage ⅠB-ⅢA and TPS ≥ 50% non-small cell lung cancer, excluding EGFR and ALK gene mutations will receive 4 cycles of Serplulimab monotherapy at 4.5mg/kg as neoadjuvant treatment before surgery. Subsequently, they will undergo surgical resection and evaluation of the effect of neoadjuvant therapy. 14 cycles of Serplulimab as adjuvant treatment. Participants will provide blood samples before neoadjuvant treatment, before the third cycle of neoadjuvant treatment, before surgery, and 4-7 days after surgery for Minimal Residual Disease（MRD） detection to assist in evaluating the treatment effect.

Participants with ⅠB(≥4cm)-ⅢA and TPS ≥ 50% non-small cell lung cancer patients, excluding EGFR and ALK gene mutations. They will receive 4 cycles of Serplulimab monotherapy at 4.5mg/kg as neoadjuvant treatment before surgery. Subsequently, they will undergo surgical resection and the effectiveness of the neoadjuvant treatment will be evaluated. After surgery, they will receive 14 cycles of Serplulimab as adjuvant treatment.

Serplulimab for Patients With Non-small Cell Lung Cancer (NSCLC) With TPS ≥ 50%: a Prospective, Single-center, Single-arm Phase 2 Study.

Prospective, Single-center, Single-arm Phase 2 Clinical Study on the Efficacy and Safety of Single-agent Neoadjuvant Therapy With Serplulimab in Patients With Non-small Cell Lung Cancer With TPS ≥ 50%.

Proportion of patients with complete response (CR) or partial response (PR) to preoperative multimodal therapy. ORR will be evaluated using RESIST1.1 by CT of the chest.

The time from enrollment to death due to any reason. The time from enrollment to death due to any reason. The time from enrollment to death due to any reason.

The time from enrollment to disease progression or death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer	NCT06305962	PDL1 Gene Mutat... Non Small Cell ...	177Lu-RAD204	18 Years -	Radiopharm Theranostics, Ltd
Serplulimab for Patients With Non-small Cell Lung Cancer (NSCLC) With TPS ≥ 50%: a Prospective, Single-center, Single-arm Phase 2 Study.	NCT06195683	Non-small Cell ... PDL1 Gene Mutat...	Serplulimab	18 Years - 75 Years	Zhejiang Cancer Hospital
177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer	NCT06305962	PDL1 Gene Mutat... Non Small Cell ...	177Lu-RAD204	18 Years -	Radiopharm Theranostics, Ltd

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