Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer

NCT06236997 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-SCLC-II-011
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy. In this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response（PR/CR/SD）will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab （Q3W）. The purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.

Conditions

Small Cell Lung Carcinoma

Keywords

ES-SCLC; Concurrent Radiochemotherapy; Adebrelimab

Outcome Measures

Primary Outcomes (1)

• 6-m PFS rate

  6-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 6th month

  6 months

Secondary Outcomes (5)

• ORR

  up to 24 months.

• PFS

  From date of the first treatment to the first documented disease progression, assessed up to 24 months

• OS

  From date of the first treatment to death due to any cause, assessed up to 24 months

• 12-m PFS rate

  12 months

• AEs

  up to 24 months

Study Arms (1)

Treatment (etoposide, carboplatin, radiation, Adebrelimab)

EXPERIMENTAL

Participants receive etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Drug: Adebrelimab; Radiation: Radiation Therapy; Drug: etoposide, carboplatin(EC)

Interventions

Adebrelimab DRUG

Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Treatment (etoposide, carboplatin, radiation, Adebrelimab)

Radiation Therapy RADIATION

Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Treatment (etoposide, carboplatin, radiation, Adebrelimab)

etoposide, carboplatin(EC) DRUG

Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Treatment (etoposide, carboplatin, radiation, Adebrelimab)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years;
• Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system) ;
• Must sign a written informed consent form prior to any study specific procedures;
• No prior treatment for ES-SCLC;
• No more than 5 lesions (including metastases),and at least one measurable lesion that meets RECIST 1.1 evaluation criteria;
• Life expectancy more than 3 months;
• ECOG PS 0-1

You may not qualify if:

• Previous treatment with radiochemotherapy for limited-stage small cell lung cancer;
• Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ;
• Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;
• Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size\<1cm;
• Patients with spinal cord compression;
• Patients with multiple liver metastases(except isolated lesion and lesion size\<2cm);
• Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
• The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Huazhong University of Science and Technology: collaborator

Study Sites (2)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Tongji Hospital, Tongji Medical College，Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Radiotherapy; EC regimen

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Qimig Wang, Doctor

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Guangyuan Hu, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qimig Wang, Doctor

CONTACT

0086-13783590691; qimingwang1006@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 1, 2024
• Study Start: February 10, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 1, 2024

Record last verified: 2023-10

Locations

CN (2)