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

Small Cell Lung Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06236997
• Other study ID #: MA-SCLC-II-011
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 10, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Henan Cancer Hospital
• Contact: Qimig Wang, Doctor
• Phone: 0086-13783590691
• Email: qimingwang1006[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants receive EC chemotherapy combined with Adebrelimab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy combined 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged 18-75 years;

2. Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) ;

3. Must sign a written informed consent form prior to any study specific procedures;

4. No prior treatment for ES-SCLC;

5. No more than 5 lesions (including metastases),and at least one measurable lesion that meets RECIST 1.1 evaluation criteria;

6. Life expectancy more than 3 months;

7. ECOG PS 0-1

Exclusion Criteria:

1. Previous treatment with radiochemotherapy for limited-stage small cell lung cancer;

2. Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ;

3. 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;

4. Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size<1cm;

5. Patients with spinal cord compression;

6. Patients with multiple liver metastases(except isolated lesion and lesion size<2cm);

7. 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;

8. The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance.

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma

Intervention

Drug:
• Adebrelimab
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.

Radiation:
• Radiation Therapy
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:
• etoposide, carboplatin(EC)
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.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Henan Cancer Hospital	Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ORR	Objective response rate is defined as the proportion of subjects who have a CR or a PR	up to 24 months.
Secondary	PFS	Progression-free survival is defined as the time from the first treatment to the first documented disease progression	From date of the first treatment to the first documented disease progression, assessed up to 24 months
Secondary	OS	Overall survival is defined as the time from the first treatment to death due to any cause.	From date of the first treatment to death due to any cause, assessed up to 24 months
Secondary	12-m PFS rate	12-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 12th month	12 months
Secondary	AEs	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	up to 24 months