Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Small Cell Lung Cancer

Adebrelimab

This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy

A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage Small Cell Lung Cancer

A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage

The incidence of grade 3 or higher adverse events

Henan Cancer Hospital

Chief physician

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

All Drugs and Chemicals

Immunomodulating Agents

hippocampal-sparing WBRT combined with SRS will be used to treat SCLC patients with baseline brain metastases during standard first-line chemotherapy combined with immunotherapy.

hippocampal-avoidance whole brain radiotherapy (WBRT) followed by stereotactic body radiotherapy (SBRT)

HA-WBRT plus SBRT

zhengfei zhu

Xiao Chu

Zhengfei Zhu, MD

This study aims to evaluate the safety and efficacy of hippocampal-sparing WBRT combined with SRS as first-line treatment for SCLC patients with brain metastases.

At present, the standard treatment for SCLC brain metastases is whole brain radiotherapy (WBRT). However, WBRT is palliative in nature due to its low dose and poor long-term control rate of intracranial lesions. At the same time, with the advent of the era of immunotherapy, a variety of PD-1/PD-L1 monoclonal antibodies combined with chemotherapy have become the standard first-line treatment for extensive-stage SCLC(ES-SCLC). Studies have shown that the survival time of SCLC patients with brain metastases is expected to be further prolonged in the era of chemotherapy and immunotherapy. Therefore, it is particularly important to further improve the control rate of intracranial lesions.

It has been confirmed in previous studies that WBRT combined with stereotactic radiotherapy for visible intracranial lesions (SRS/SRT) can effectively improve the control rate of intracranial lesions. However, most of the previous studies of WBRT combined with SRT for brain metastases did not include or only included a very small number of patients with SCLC. Studies on thoracic radiotherapy for limited-stage small cell lung cancer have found that an increase in radiotherapy dose can significantly improve the prognosis of patients with SCLC, which was previously considered to be highly radiosensitive. It is reasonable to think that SRS combined with WBRT for SCLC brain metastases may improve the prognosis of patients.

WBRT is known to cause severe cognitive impairment, which has also led to the reluctance of some patients to undergo WBRT. In the era of chemotherapy, the NRG-CC001 study showed that Hippocampal avoidance WBRT (HA-WBRT) could better protect the cognitive function of patients without affecting the prognosis of patients. The 2022 ASTRO guidelines have clearly recommended the use of hippocampal protection techniques in WBRT. Considering the lack of previous literature on the use of SRS combined with WBRT in SCLC patients in the chemo-immunotherapy era, The aim of this study is to adopt the dose fractionation of SRS combined with WBRT, which has been proven to be safe in the treatment of brain metastases from NSCLC, and to evaluate the safety of this treatment mode in SCLC patients with brain metastases receiving standard first-line chemoimmunotherapy.

In summary, this study aims to evaluate the safety and efficacy of hippocampal-sparing WBRT combined with SRS in the first-line treatment of SCLC patients with baseline brain metastases who are suitable for SRS treatment during the standard first-line chemotherapy combined with immunotherapy.

For ES-SCLC patients with baseline brain metastasis enrolled in this study, standard chemo-immunotherapy will be delivered every 3 weeks.

Simulation for radiotherapy should be performed at baseline, and WBRT should be completed no later than the start of the third course of systemic treatment. The WBRT dose is 30Gy/10Fx. For patients without brain metastases within 1cm of the hippocampus, hippocampal avoidance technology should be employed. After WBRT, the treating physician will perform another simulation for subsequent SRS treatment to the brain lesions. SRS should be completed no later than the start of the fourth course of drug treatment. Specific SRS dose should be as follows: 16Gy for tumors with a diameter ≤ 2cm; 12Gy for tumors with a diameter of between 2cm and 3cm. WBRT and SRS should be performed during the interval between two systemic drug treatments, concurrent (on the same day) brain radiotherapy with chemo-immunotherapy treatment should be avoided.

WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases

A Phase I/II Study to Evaluate the Safety and Efficacy of Hippocampal-avoidance Whole Brain Radiotherapy Followed by Stereotactic Radiotherapy for Extensive-stage Small Cell Lung Cancer With Baseline Brain Metastases

dose-limiting toxicities(DLTs) were assessed according to CTCAE 5.0 criteria and included the following three conditions, with the exception of asymptomatic biochemical abnormalities: (1) grade 3 toxicity lasting for more than 7 consecutive days; (2) Grade 4 toxicity excluding neutropenia and thrombocytopenia; (3) Treatment-related grade 5 adverse events could not be excluded.

1-year intracranial progression-free survival (iPFS) rate was defined as proportion of patients without intracranial disease progression or death at 1 year of follow-up

overall survival(OS) was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.

Time to intracranial progression was defined as the time from enrollment for treatment to the observation of progression of intracranial disease.

learning and memory function was assessed at 2, 4, 6, and 12 months from the first day of radiotherapy using the Hopkins Verbal Learning Test (HVLT-R)

processing speed and executive function was assessed at 2, 4, 6, and 12 months from the first day of radiotherapy using the trail making test (TMT-Part A, to assess processing speed, and TMT-Part B, to assess executive function).

Fudan University

Professor

Antineoplastic Agents

Antibodies

Niraparib

Immunoglobulins

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

200 mg orally once daily, until PD 300 mg once daily if body weight ≥77 kg and platelets ≥150 g/L, until PD

Heidi Roschitzki, PhD

Susanne Roux

Youssef Oulkohuir

Nicolas Cloarec

Simon Deshayes

Maurice Pérol

Angelo Delmonte

Antonio Passaro

Giulio Metro

Adolfo Favaretto

Rosario Garcia Campelo

Teresa Morán

Ana Laura Ortega Granados

Manuel Domine

Mariano Provencio

Janthur Wolf-Dieter

Christine Waibel

David König

Ferdinando Cerciello

Markus Jörger

Alexandre Huber

Laetitia Mauti

Markus Joerger, MD-PhD

RAISE is an international, multicentre, single-arm phase II trial. The trial treatment consists of the addition of niraparib, 200 mg orally once daily to anti-PD-L1 antibody maintenance. The primary objective of this trial is to assess the clinical efficacy of the addition of niraparib to anti-PD-L1 monoclonal antibody maintenance treatment in patients with SLFN11-positive ED-SCLC which has not progressed following standard first-line chemo-immunotherapy.

Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC

A Single-arm Phase II Trial of the Addition of Niraparib to Anti-PD-L1 Antibody Maintenance in Patients With SLFN11-positive, Extensive-disease Small Cell Lung Cancer.

Defined as the rate of patients without a PFS event at 3 months after enrolment

Defined as the time from the date of enrolment until documented progression

Defined as the time from the date of enrolment until death from any cause

Defined as the rate of patients, among all enrolled patients, that achieve a complete response (CR) or partial response (PR) or stabilisation of disease (SD, at least at week 6) by investigator assessment

Adverse events according to CTCAE v5.0 (any-cause as well as treatment-related) including adverse events leading to dose interruptions, withdrawal of protocol treatment and death

GlaxoSmithKline

Development Limited

ETOP IBCSG Partners Foundation

Death

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antibodies, Bispecific

Chiauranib

Protein Kinase Inhibitors

Subjects receive AK104 once every 3 weeks plus Chiauranib once a day until intolerable toxicity, no more clinical benefit as judged by the investigator, or completion of 24 months of treatment, or meeting other criteria for termination of treatment in the protocol, whichever occurs first.

AK104 IV infusion once every 3 weeks；Chiauranib once a day oral

AK104 IV infusion；Chiauranib oral

Ying Cheng, Professor

A Phase Ib/II open label,international multicentre study to evaluate the efficacy and safety of anti-PD-1 and CTLA-4 bispecific antibody AK104 in combination with Chiauranib in Patients with Extensive Stage Small Cell Lung Cancer Who Failed First-line Platinum-based Chemotherapy in Combination with PD1/PDL1 Inhibitors

Small cell lung cancer (SCLC) consists 15% of the lung cancer.Because of the high malignancy, poor cell differentiation, and rapid proliferation of SCLC, 65% of the patients were in the extensive stage at their first presentation in the hospital with a very poor prognosis. There were few options of second-line therapies for patients who experienced progress disease during or after the end of first-line platinum-based regimens. Several studies showed that PD-1/PD-L1 inhibitors had synergistic anti-tumor effects with anti-vascular endothelial growth factor(VEGF) agents, i.e., PD-1/PD-L1 inhibitors could restore the anti-tumor effect of the immune system by blocking PD-L1, and anti-VEGF agents could improve the efficacy of the former by blocking the immunosuppressive effect of VEGF and promoting the infiltration of T cells in tumor tissues. Immunotherapy in combination with antiangiogenic therapy may become a trend in the treatment of extensive stage small cell lung cancer(ES-SCLC). The aim of this international multicentre phase Ib/II trial is to evaluate the efficacy-objective response rate according to RECIST criteria and safety-incidence and severity of adverse events.The patients' recruitment timeframe is set at 16 months and approximately 42 patients will be included.

A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer

A Phase Ib/II Clinical Study of Anti-PD-1 and CTLA-4 Bispecific Antibody, Cadonilimab(AK104), in Combination With Chiauranib in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer Who Failed First-line Platinum-based Chemotherapy in Combination With Programmed Cell Death-1(PD1)/Programmed Cell Death Protein Ligand-1(PDL1) Inhibitors

The ATRX gene mutation status in peripheral blood will be determined, and its correlation with efficacy indicators such as ORR, PFS and OS will be analyzed.

The expression of proteins related to SCLC subtype in tumor tissue samples will be detected by immunohistochemistry (IHC) and its correlation with efficacy will be analyzed.

ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

Incidence and severity of AEs is aim to evaluate the safety of AK104 in combination with Chiauranib.

Disease control rate (DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR and PR and stable disease(SD) per RECIST v1.1.

Duration of response (DoR) is defined as the period from the first documentation of confirmed response (CR or PR) to the first documentation of progressive disease(PD) (as per RECIST v1.1) or death due to any cause, whichever occurs first.

Time to response (TTR) is defined as the time from the first dose of investigational products until the first confirmation of CR or PR.

Progression-free survival (PFS) is defined as the time from the first dose of investigational products until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.

Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause.

Serum concentrations of AK104 and plasma concentrations of Chiauranib in individual subjects at different time points after administration of AK104 in combination with Chiauranib.

The immunogenic potential of AK104 in combination with Chiauranib will be assessed by summarizing the number and percentage of subjects with detectable antidrug antibody(ADA).

Chipscreen Biosciences, Ltd.

Akeso

Etoposide

Carboplatin

Somatostatin

Atezolizumab

Etoposide phosphate

Radiopharmaceuticals

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

RYZ101 (Actinium 225 radiolabeled somatostatin analog (SSA)) 6.5 MBq/175 μCi in combination with standard of care (SoC) carboplatin + etoposide + atezolizumab

6.5 MBq/175 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level 1

8.3 MBq/225 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level 2

10.2 MBq/275 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level 3

4.6 MBq/125 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level -1

1200 mg administered IV for 4 x 21-day cycles, followed by 1680 mg every 28-days (maintenance)

AUC 5-6 administered IV for 4 x 21-day cycles

80-100 mg/m2 administered IV on 3 consecutive days for 4 x 21-day cycles

RayzeBio Clinical Trials

Jonathan Goldman

Megan Gee

Claire Mulvey, MD

Ephraim Parent, MD

Caitlin Mynard

Justin Rineer, MD

Mark Crystal

Manish Thakur, MD

Heather Austin

Krisha Howell, MD

Aaron Mansfield, MD

Marlene Bridwell

Robert Langdon, MD

John Waldron

John Waldron, MD

Sonam Puri, MD

Iris G. Garcia-Acevedo, BSN-RN

Noridza Rivera-Rodriguez, MD

Denise Ferreira, MD

This study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC.

Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC

Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-SCLC)

RP2D as determined by incidence rate of DLTs

Safety and tolerability of RYZ101 in combination with SoC as measured by incidence and severity of AEs including SAEs, laboratory changes and other safety findings

Durable ORR defined as the proportion of subjects with measurable disease at baseline who achieve confirmed CR or PR according to RECIST v1.1 lasting at least 4 months

ORR as assessed by the Investigator according to RECIST v1.1

Only for subjects with a RECIST v.1.1 response, assessed by the Investigator according to RECIST v1.1

OS as defined from the time of first dose of RYZ101 or first dose of SoC therapy to the date of death due to any cause

BOR as assessed by the Investigator according to RECIST v1.1

Disease control rate (PR + CR + SD) as assessed by the Investigator according to RECIST v1.1

PFS as defined from date of first dose of RYZ101 or first dose of SoC therapy to the date of progression as assessed by the Investigator according to RECIST v1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage Small Cell Lung Cancer	NCT06267170	SCLC,Extensive ...	Adebrelimab	18 Years -	Henan Cancer Hospital
WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases	NCT06243003	SCLC,Extensive ... Brain Metastase...	HA-WBRT plus SB...	18 Years -	Fudan University
Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC	NCT05718323	SCLC,Extensive ... SLFN11-positive	Niraparib	18 Years -	ETOP IBCSG Partners Foundation
WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases	NCT06243003	SCLC,Extensive ... Brain Metastase...	HA-WBRT plus SB...	18 Years -	Fudan University
A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer	NCT05505825	SCLC,Extensive ...	AK104 IV infusi...	18 Years - 75 Years	Akeso
Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC	NCT05595460	SCLC,Extensive ...	RYZ101 Dose Lev... RYZ101 Dose Lev... RYZ101 Dose Lev... RYZ101 Dose Lev... Atezolizumab Carboplatin Etoposide	18 Years -	RayzeBio, Inc.

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