Auto-HSCT-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for ES-SCLC

NCT06597513 | Not Yet Recruiting Phase 1

• 1 other identifier: CROC-24-07
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults. It will also assess the safety of this treatment approach. The main questions it aims to answer are: Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates? What medical problems do participants experience whild undergoing this treatment? Participants will: Complete two 21-days cycles of standard-dose etoposide and carboplatin, followed by G-CSF for stem cell mobilization. Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles. If eligible, participants will receive etoposide and carboplatin plus adebrelimab for four cycles. Finally, participants may enter a maintenance phase with adebrelimab. Throughout the trial, participants will: Visit the clinic every 21 days for check-ups and tests. Imaging examination every 6 weeks. Followed up by telephone every 2 months

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

Auto-HSCT; Adebrelimab; Dose-Dense Chemotherapy; Etoposide; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0, detailed descriptions of the events, the onset timing, severity grade, therapeutic interventions undertaken, and the potential correlation with the investigational medication.

  Time Frame: Followed up every 21 days.

Secondary Outcomes (3)

• Median Progression Free Survival (mPFS)

  Imaging examination every 6 weeks.

• 12-months OS rate

  Followed up by telephone every 2 months

• 24-months OS rate

  Followed up by telephone every 2 months

Study Arms (1)

auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab

EXPERIMENTAL

Complete two 21-days cycles of standard-dose etoposide 80-100 mg/m² on days 1-3 and carboplatin AUC 5-6 on day 1, followed by G-CSF for stem cell mobilization. Receive dose-dense etoposide 160-200 mg/m² on days 1-3 and carboplatin AUC 10-12 on day 1 followed by autologous stem cell reinfusion for two 21-day cycles. If eligible, participants will receive standaed-dose etoposide and carboplatin plus adebrelimab 1200 mg on day 1 for four cycles. Finally, participants may enter a maintenance phase with adebrelimab1200 mg every 21 days.

Drug: auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab

Interventions

auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab DRUG

Induction: Two 21-day cycles of standard-dose etoposide 80-100 mg/m² on days 1-3 and carboplatin AUC 5-6 on day 1. Those without disease progression will advance to consolidation treatment. Consolidation: Stem cell mobilization with G-CSF will be start when white blood cell count is at its nadir post-chemotherapy. After recovery, peripheral blood stem cells will be collected via apheresis, evaluated, and cryopreserved if adequate. Dose-dense etoposide 160-200 mg/m² on days 1-3 and carboplatin AUC 10-12 on day 1 for two 21-day cycles. Within 48-72 hours after the first cycle, autologous peripheral blood stem cells will be reinfused with G-CSF. Further consolidation will depend on hematopoietic recovery with standard-dose EC plus adebrelimab 1200 mg on day 1 for four 21-day cycles. Maintenance: Adebrelimab 1200 mg every 21 days will be given until disease progression, intolerable toxicity, death, patient withdrawal, or investigator decision.

Also known as: auto-HSCT, Dose-Dense Chemotherapy, Adebrelimab

auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed small cell lung cancer (SCLC) staged as extensive-stage (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) classification.
• ES-SCLC dose not received prior systemic treatment.
• History of localized-stage SCLC with prior radiotherapy and chemotherapy, with the requirement for definitive treatment, and a minimum of 6 months interval from the last treatment to diagnosis of ES-SCLC.
• CT or MRI scan ≤28 days prior to the first dose of study medication, with at least one target lesion that has not been irradiated (RECIST v1.1 criteria).
• Male or female patients aged ≥18 and ≤70 years.
• ECOG Performance Status of 0 or 1.
• Life expectancy ≥12 weeks.
• Adequate organ system function (excluding use of any blood components or growth factors during screening).
• Male or female participants must agree to use appropriate contraception (e.g., intrauterine device, contraceptive pills, or condoms) from the start of the study treatment until 6 months after the last study treatment; women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
• Subjects voluntarily participate in this study and sign the informed consent form (ICF).

You may not qualify if:

• Histologically or cytologically confirmed mixed SCLC and NSCLC.
• Prior treatment with any T-cell co-stimulatory or immune checkpoint inhibitors, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T-cell targeted agents.
• Prior treatment with vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) inhibitors.
• Symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. For treated brain metastases, the following criteria must be met: no progression on MRI ≥4 weeks post-treatment, completion of treatment ≥28 days before the first dose of study drug, and no need for systemic corticosteroids (\>10 mg/day prednisone or equivalent) ≤14 days before the first dose.
• Hematologic disorders including, but not limited to, lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, or myelodysplastic syndromes.
• Symptomatic third-space fluid accumulation, such as uncontrolled pericardial effusion, pleural effusion, or ascites despite drainage or other treatments.
• Active, known, or suspected autoimmune diseases. Exceptions include vitiligo, type 1 diabetes, autoimmune thyroiditis with only hormone replacement therapy, or conditions unlikely to relapse without external stimuli.
• Use of systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressants ≤14 days before the first dose of study drug. Inhaled or topical corticosteroids and adrenal replacement therapy are allowed if no active autoimmune disease.
• Receipt of or planned vaccination with live vaccines ≤4 weeks before the first dose of study drug.
• Interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis requiring corticosteroids, active pneumonia, or severe pulmonary dysfunction.
• Active tuberculosis or history of active tuberculosis ≤48 weeks before screening, regardless of treatment status.
• Toxicities from prior anticancer treatment other than alopecia and fatigue must have resolved to CTCAE v4.03 ≤ Grade 1 before the first dose. Long-term sequelae such as platinum-based neurotoxicity are allowed if anticipated to be stable.
• Imaging (CT or MRI) showing tumor invasion of major vessels, hemoptysis symptoms within 3 months before screening, or daily hemoptysis ≥2.5 mL.
• Minor surgery (including catheter placement) ≤48 hours before the first dose of study drug.
• Current or recent use of aspirin (\>325 mg/day) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function ≤10 days before the first dose.

Sponsors & Collaborators

• Zhou Chengzhi: lead

Related Publications (1)

• Liu M, Guan W, Xie X, Li Z, Qiu G, Lin X, Xie Z, Zhang J, Qin Y, Huang Z, Xu X, Zhou C. Phase I Clinical Trial of Autologous Hematopoietic Stem Cell Transplantation-Supported Dose-Intensified Chemotherapy With Adebrelimab as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer. Clin Lung Cancer. 2025 May;26(3):e236-e241. doi: 10.1016/j.cllc.2024.12.013. Epub 2024 Dec 27.

  PMID: 39848827 DERIVED

Study Officials

• Chengzhi Zhou, MD

  The First Affiliated Hospital of Guang Zhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Chengzhi Zhou, MD

CONTACT

13560351186; doctorzcz@163.com

Ming Liu, MD

CONTACT

18688380929; mingliu128@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share