Auto-HSCT-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for ES-SCLC
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhou Chengzhi
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab
DrugInduction: 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: auto-HSCT-Supported Dose-Dense Chemotherapy With AdebrelimabExperimental treatment 1 intervention
Trial outcomes
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
Time Frame: Followed up every 21 days.Secondary outcomes
1
Median Progression Free Survival (mPFS)
The time of disease progression or death in 50% of patients according to K-M curve.
Time frame
Imaging examination every 6 weeks.2
12-months OS rate
The percentage of patients survival in the 12th months according to the K-M curve.
Time frame
Followed up by telephone every 2 months3
24-months OS rate
The percentage of patients survival in the 24th months according to the K-M curve.
Time frame
Followed up by telephone every 2 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhou Chengzhi
Lead sponsor
Guangzhou Institute of Respiratory Disease
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: