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Clinical Trial NCT06236997 for Small Cell Lung Carcinoma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer Phase 2 48 Immunotherapy
Clinical Trial NCT06236997 is designed to study Treatment for Small Cell Lung Carcinoma. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on February 10, 2024 until the study accrues 48 participants. Led by Henan Cancer Hospital, this study is expected to complete by December 31, 2027. The latest data from ClinicalTrials.gov was last updated on February 1, 2024.
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 r...
Show MoreDetailed 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.
Official Title
Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer
Conditions
Small Cell Lung CarcinomaOther Study IDs
- MA-SCLC-II-011
NCT ID Number
Start Date (Actual)
2024-02-10
Last Update Posted
2024-02-01
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
48
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
ES-SCLC
Concurrent Radiochemotherapy
Adebrelimab
Concurrent Radiochemotherapy
Adebrelimab
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTreatment (etoposide, carboplatin, radiation, Adebrelimab) 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...Show More | 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...Show More 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...Show More 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...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
ORR | Objective response rate is defined as the proportion of subjects who have a CR or a PR | up to 24 months. |
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 |
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 |
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 |
AEs | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 24 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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.
Henan Cancer HospitalHuazhong University of Science and Technology361 active studies to exploreStudy Central Contact
Contact: Qimig Wang, Doctor, 0086-13783590691, [email protected]
2 Study Locations in 1 Countries
Henan
Henan Cancer Hospital, Zhengzhou, Henan, 450000, China
Qiming Wang, Doctor, Contact, 0086-13783590691, [email protected]
Hubei
Tongji Hospital, Tongji Medical College，Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China
Guangyuan Hu, Doctor, Contact, 0086-13886000095, [email protected]