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New treatment option for SCLC, Limited Stage
Official title A Multicenter, Open-label, Randomized, Prospective Clinical Study of Adebrelimab Consolidation Therapy for Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Without Progression After Concurrent Chemoradiotherapy
ClinicalTrials.gov ID: NCT07559786
What this study is testing
- What it's testing
- This study aims to evaluate the efficacy and safety of adebrelimab consolidation therapy after progression-free response of concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer. This study plans to enroll patients with untreated limited-stage small cell lung cancer who meet the inclusion criteria.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1.Age ≥ 18 and ≤ 75 years, regardless of gender. 2.Histopathologically confirmed, untreated limited-stage small cell lung cancer (LS-SCLC) (stage...
- Hematology: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without G-CSF support within 14 days before first treatment; lymphocyte count (LC) ≥...
- Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN (≤3.0 mg/dL for...
- Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min (calculated by Cockcroft-Gault, CKD-EPI, or MDRD equation)...
- Coagulation: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
You likely can't join if
- Histologically confirmed combined small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC).
- Prior systemic anti-tumor therapy or immune checkpoint inhibitor therapy for SCLC.
- Extensive-stage SCLC.
- Presence of malignant pleural effusion. If aspiratable pleural effusion is present during screening, at least one thoracentesis must be performed to...
- people with known or suspected interstitial lung disease (ILD); other moderate-to-severe pulmonary diseases that may interfere with the detection or...
- History of active, known or suspected autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus...
See the full eligibility criteria
Who can join
- 1.Age ≥ 18 and ≤ 75 years, regardless of gender. 2.Histopathologically confirmed, untreated limited-stage small cell lung cancer (LS-SCLC) (stage I-III per AJCC 8th edition, with all lesions encompassed in a tolerable...
- Hematology: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without G-CSF support within 14 days before first treatment; lymphocyte count (LC) ≥ 0.5×10⁹/L; platelet count (PLT) ≥ 90×10⁹/L without transfusion, G-CSF, or...
- Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN (≤3.0 mg/dL for patients with confirmed Gilbert syndrome).
- Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min (calculated by Cockcroft-Gault, CKD-EPI, or MDRD equation); urine protein \< 2+ (if urine protein ≥ 2+, 24-hour urine protein must...
- Coagulation: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%. 9.Sexually active people of reproductive potential (non-sterilized) must agree to use at least one medically accepted contraceptive method during study...
What rules you out
- Histologically confirmed combined small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC).
- Prior systemic anti-tumor therapy or immune checkpoint inhibitor therapy for SCLC.
- Extensive-stage SCLC.
- Presence of malignant pleural effusion. If aspiratable pleural effusion is present during screening, at least one thoracentesis must be performed to confirm the presence or absence of malignant cells.
- people with known or suspected interstitial lung disease (ILD); other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely impair...
- History of active, known or suspected autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc...
- Concomitant malignancy diagnosed ≤3 years before first study treatment, except adequately treated papillary thyroid carcinoma, cervical carcinoma in situ, basal or squamous cell skin cancer, locally controlled prostate...
- History of clinically significant cardiovascular disease, including but not limited to: Congestive heart failure (NYHA class \>2); Unstable angina; Myocardial infarction within 3 months before signing ICF; Any severe...
- Severe infection within 4 weeks before first treatment, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; active infection of CTCAE grade ≥2 requiring systemic antibiotics within...
- Active tuberculosis within 1 year before enrollment by history or CT scan, or history of active tuberculosis \>1 year ago without standard treatment.
- History of immunodeficiency, including positive HIV serology.
- Active hepatitis B or hepatitis C.(HBsAg-positive or HBcAb-positive people may be enrolled if HBV DNA \< upper limit of normal (ULN) of the local laboratory (if no ULN, HBV DNA \<1000 copies/mL or 500 IU/mL); HCV...
- Receipt of systemic immunosuppressive therapy within 14 days before first treatment, including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.