Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Cisplatin

Olaparib

Etoposide phosphate

Enzyme Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Participants will receive the following treatment regimens: LDRT cisplatin + etoposide + sugemalimab+olaparib. Induction treatment will be administered on a 21-day cycle for four cycles. LDRT will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with sugemalimab and olaparib. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).

The LDRT deals with primary tumour in a 15 Gy of 5fractions over five days, starting from Day 1 in the first cycle.

Low-dose radiotherapy

Etoposide will be administered intravenously at a dose of 100 mg/m\^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

Cisplatin will be administered as intravenous infusion at a dose of 25 mg/m\^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

Sugemalimab will be administered by intravenous infusion at a dose of 1200mg on Day 1 of each 21-day cycle for a maximum of 2 years or progressive disease or intolerable toxicity.

Sugemalimab

Olaparib will be administered orally at a dose of 150mg qod Day 1,3,5,7 or 150 mg qd/150 mg bid/300mg in the morning and 150mg in the evening/300 mg bid on Day 1-7 of each 21-day cycle for a maximum of 2 years or progressive disease or intolerable toxicity.

Min Yu, MD

You Lu, MD

You Lu

Min Yu

The purpose of this study was to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) combined with sugemalimab, olaparib, chemotherapy in the first-line treatment of SLFN-11 positive extensive stage small cell lung cancer.

This study consists of dose escalation and dose expansion in China. Subjects who fulfil all the inclusion criteria and none of the exclusion criteria will be enrolled and receive treatment with Sugemalimab, Etoposide/Cisplatin Chemotherapy and Olaparib for 4 cycles with LDRT in the first cycle. Sugemalimab in combination with olaparib will be administered for maintenance therapy after 4 cycles. Sugemalimab will be administered at a dose of 1200 mg every 3 weeks (Q3W) in the first day of every cycle. The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from day 1 in the first cycle. Dose of olaparib will identify by assessed recommended dose for expansion (RDE) in dose escalation stage.A dose expansion stage will be conducted after dose escalation. The primary endpoint is safety.

Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC

Phase I Study of Low-Dose Radiotherapy Plus Chemotherapy and Sugemalimab and Olaparib for First-Line Treatment of SLFN-11 Positive Extensive Stage Small Cell Lung Cancer

To determine the RDE of olaparib in subjects with Extensive Stage-SCLC when combined with low-Dose Radiotherapy, chemotherapy and sugemalimab.

The time from the date of first dosing of sugemalimab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).

PFS rate at 6 months and 1 year, defined as the proportion of patients who have not experienced disease progression or death from any cause at 6 months and 1 year separately, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST1.1).

OS, defined as the time from initiation of study treatment to death from any cause.

OS rate at 1 year, 1.5 years and 2 years, defined as the proportion of patients who have not experienced death from any cause at 1 year ,1.5 years and 2 years.

According to the evaluation criteria of RECIST1.1

Sichuan University

Chief of Thoracic Cancer Ward

Symptoms and General Pathology

Neoplasm, Residual

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Intravenous infusion (IV) of Sugemalimab 1200 mg at least 60 minutes on Day 1 of each treatment cycle, every 3 weeks (21 days), for 1 year or until disease progression or intolerable toxicity.

Intravenous infusion (IV) of placebo at least 60 minutes on Day 1 of each treatment cycle, every 3 weeks (21 days), for 1 year or until disease progression or intolerable toxicity.

Recombinant anti-PD-L1 fully human monoclonal antibody

Placebo

Shen Zhao, MD

Li Zhang, MD

Yan Huang, MD

The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.

This study is planned to enroll approximately 346 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to the experimental and control arm. The experimental arm would receive sugemalimab, while the control arm would receive placebo.Tumor assessment will be conducted using computed tomography/magnetic resonance imaging and MRD detection will be performed along with radiologic review during each visit. The above assessment will be conducted every 12 weeks for the first 2 years, every 24 weeks for the third year, and annually thereafter until confirmed disease progression per RECIST 1.1 or death.The primary endpoint is PFS ,which is defined as the time from the date of randomization to the date of disease progression (per RECIST 1.1), any cause of death, loss to follow-up, or initiation of new antitumor therapy, whichever occurred first.

Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT

A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study of Sugemalimab as Consolidation Therapy in Patients With Limited-stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy

Evaluated according to RECIST 1.1 criteria by researchers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC	NCT06217757	Lung Cancer Extensive-stage...	Low-dose radiot... Etoposide Cisplatin Sugemalimab Olaparib	18 Years - 75 Years	Sichuan University
Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT	NCT05623267	Limited Stage S...	Sugemalimab Placebo	18 Years -	Sun Yat-sen University
Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT	NCT05623267	Limited Stage S...	Sugemalimab Placebo	18 Years -	Sun Yat-sen University
Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT	NCT05623267	Limited Stage S...	Sugemalimab Placebo	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for sugemalimab

Every month we try and update this database with for sugemalimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sugemalimab

Every month we try and update this database with for sugemalimab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sugemalimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.