Clinical trial NCT06943664: Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer
Official title: Phase II Trial: Photoimmunotherapy and Anti-PD1 in Patients With Refractory Inoperable and Metastatic Non-Small Cell Lung Cancer
Conditions: Lung Non-Small Cell Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Refractory Lung Non-Small Cell Carcinoma
Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Summary: This phase II trial tests how well photoimmunotherapy (PIT) with ASP-1929 in combination with cemiplimab works in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC) that has not responded to previous treatment (refractory), that is not suitable for surgery (inoperable), or that has spread from where it first started to other places in the body (metastatic). PIT is a treatment that combines drugs that become active when exposed to light, such as ASP-1929, with immunotherapy to target and kill tumor cells. ASP-1929 combines cetuximab with a light-sensitive component, sarotalocan. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called epidermal growth factor receptor (EGFR), which is found on some types of tumor cells. This may help keep tumor cells from growing. Sarotalocan is a fluorescent dye, infrared-activated fluorescent dye 700, that is light sensitive, and when activated by a special type of laser light, helps destroy or change tumor cells. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving PIT with ASP-1929 in combination with cemiplimab may kill more tumor cells in patients with refractory, inoperable, or metastatic stage IIIB-IV NSCLC.
Interventions:
description: Undergo blood sample collection
name: Biospecimen Collection
other_name: Biological Sample Collection
Biospecimen Collected
Specimen Collection
type: Procedure
description: Given IV
name: Cemiplimab
other_name: Cemiplimab RWLC
Cemiplimab-rwlc
Libtayo
REGN 2810
REGN-2810
REGN2810
type: Biological
description: Given IV
name: Cetuximab Sarotalocan Sodium
other_name: ASP 1929
ASP-1929
ASP1929
Cet-IR700
Cetuximab-IR700 Conjugate RM-1929
RM-1929
type: Biological
description: Undergo CT or PET/CT
name: Computed Tomography
other_name: CAT
CAT Scan
CT
CT Scan
Computed Axial Tomography
Computerized Axial Tomography
Computerized Tomography
Computerized Tomography (CT) scan
Computerized axial tomography (procedure)
tomography
type: Procedure
description: Ancillary studies
name: Electronic Health Record Review
type: Other
description: Undergo EBUS
name: Endobronchial Ultrasound Bronchoscopy
other_name: EBUS
Endobronchial Ultrasound
type: Procedure
description: Undergo MRI
name: Magnetic Resonance Imaging
other_name: MR
MR Imaging
MRI
MRI Scan
MRIs
Magnetic Resonance
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging Scan
Magnetic resonance imaging (procedure)
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
NMR Imaging
NMRI
Nuclear Magnetic Resonance Imaging
Structural MRI
sMRI
type: Procedure
description: Undergo EB-PIT
name: Photoimmunotherapy
other_name: Photodynamic Light Therapy
type: Procedure
description: Undergo I-PIT
name: Photoimmunotherapy
other_name: Photodynamic Light Therapy
type: Procedure
description: Undergo PET/CT
name: Positron Emission Tomography
other_name: Medical Imaging, Positron Emission Tomography
PET
PET Scan
PT
Positron Emission Tomography Scan
Positron emission tomography (procedure)
Positron-Emission Tomography
type: Procedure
description: Undergo robotic bronchoscopy
name: Robotic Bronchoscopy
other_name: Robot-Assisted Bronchoscopy
Robotic-Assisted Bronchoscopy
type: Procedure
description: Undergo VATS
name: Video-Assisted Thoracic Surgery
other_name: VATS
Video-Assisted Thoroscopic Surgery
type: Procedure
Study arms:
design_group_description: Patients receive cemiplimab IV over 30 minutes on days 1, 22, and 43 of each cycle and ASP-1929 IV over 2 hours on day 8 of each cycle. Patients undergo EB-PIT via standard of care VATS once on day 9 of cycle 1 or I-PIT via EBUS or robotic bronchoscopy up to 3 times on day 9 of cycles 1, 2, and/or 3. Cycles repeat every 9 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT and/or PET/CT or MRI throughout the study.
design_group_title: Treatment (photoimmunotherapy, ASP-1929, cemiplimab)
design_group_type: Experimental
Sponsor: Roswell Park Comprehensive Cancer Center
Collaborators: Rakuten Medical, Inc.
Drug name mappings:
name: 塞普利单抗
lang: CN
name: Cemiplimab-RWLC
lang: EN
name: セミプリマブ（遺伝子組換え）
lang: JP
name: 沙西妥昔单抗
lang: CN
name: Cetuximab Sarotalocan Sodium (Genetical Recombination)
lang: EN
name: セツキシマブ　サロタロカンナトリウム（遺伝子組換え）
lang: JP