A Phase 2 interventional study of Adebrelimab + Chemotherapy + Radiotherapy in Small Cell Lung Cancer (SCLC) and SCLC, Extensive Stage, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
This is a phase II study evaluating a novel combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial induction phase with the drug Adebrelimab plus standard chemotherapy and low-dose radiotherapy, followed by an Adebrelimab maintenance phase. The primary objective is to assess the efficacy of this approach in prolonging overall survival (OS) and to evaluate its safety in approximately 25 patients.
This is an exploratory Phase II clinical trial for previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study evaluates a two-phase treatment strategy: patients first receive induction therapy with Adebrelimab combined with standard chemotherapy (EC or EP regimen) and concurrent low-dose radiotherapy (5 Gy × 5 fractions); patients achieving disease control then proceed to the maintenance phase with Adebrelimab for up to 2 years. The primary objective is to assess the regimen's efficacy in prolonging overall survival (OS). Secondary objectives include evaluating progression-free survival (PFS), objective response rate (ORR), and safety. The study plans to enroll approximately 25 patients.
1,240 studies on the registry are indexed under Small Cell Lung Carcinoma; 354 are open to participants now.
This study's planned enrollment of 25 is below the median of 56 across 1,062 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 493 studies on the registry; 292 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 4, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
7. Adequate hematological and organ function, i.e., meeting the following criteria:
a) Hematology (no blood transfusion or blood products and no use of G-CSF or other hematopoietic growth factors for correction within 14 days): i. Absolute neutrophil count (ANC) ≥1.5×10\^9/L (1,500/mm\^3); ii. Platelet count (PLT) ≥100×10\^9/L (100,000/mm\^3); iii. Hemoglobin (HB) ≥80 g/L. b) Renal: i. Calculated creatinine clearance (CrCl) ≥50 mL/min; ii. Urine protein \<2+ or 24-hour urine protein \<1.0 g. c) Hepatic: i. Serum total bilirubin (TBil) ≤1.5×ULN; ii. AST and ALT ≤2.5×ULN; iii. Serum albumin (ALB) ≥28 g/L. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN.
e) Cardiac: i. Left ventricular ejection fraction (LVEF) ≥50%.
8. Female patients must meet one of the following conditions:
i. Serum pregnancy test within 3 days before drug administration must be negative; ii. Agree to use contraceptive measures with an annual failure rate \<1% (from signing the ICF until at least 6 months after the last dose of the study drug); iii. Must not breastfeed.
Exclusion Criteria:
Patients receive Adebrelimab (1200 mg IV Q3W) combined with standard chemotherapy (EC or EP regimen) for 4 induction cycles. Concurrent low-dose radiotherapy (5 Gy per fraction for 5 fractions) is administered during Cycle 1 or Cycle 2. Following induction, patients without disease progression (non-PD) continue to receive Adebrelimab (1200 mg IV Q3W) as maintenance therapy for up to 2 years, or until disease progression, unacceptable toxicity, or withdrawal of consent.
Combination Product: Adebrelimab + Chemotherapy + Radiotherapy
Participants receive a two-phase treatment regimen. Induction (4 fixed cycles, q3w): Adebrelimab (1200 mg IV over 60 minutes, Day 1) followed by investigator's choice of standard platinum-etoposide chemotherapy (EC regimen: Carboplatin AUC=5 on Day 1 + Etoposide 100 mg/m² on Days 1-3; or EP regimen: Cisplatin 75 mg/m² on Day 1 + Etoposide 100 mg/m² on Days 1-3). Concurrent hypofractionated radiotherapy to the primary lung lesion (5 Gy per fraction for 5 fractions) is administered during Cycle 1 or Cycle 2. Maintenance: Patients without disease progression after 4 cycles continue Adebrelimab (1200 mg IV, q3w) for up to 2 years, until disease progression (per RECIST v1.1), unacceptable grade ≥3 immune-related toxicity, or withdrawal of consent.
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Time frame: From enrollment until death from any cause, assessed up to approximately 24 months.
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Time frame: From enrollment until disease progression or death, assessed up to approximately 24 months.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients achieving a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Independent Review Committee (IRC) according to RECIST v1.1. Patients must have measurable disease at baseline.
Time frame: Assessed at baseline, after induction, and every 3 months during maintenance, up to approximately 24 months.
Safety and Tolerability
Incidence, severity, and frequency of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
Time frame: From enrollment until 90 days after the last dose of study treatment.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Sep 2027, 9 months later.
Of 154 non-industry phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 83. This study's planned 9 months is below that.
Counting every sponsor, half of 203 studies reached it within 44 months; a quarter within 29 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital →