Adebrelimab Plus Chemoradiotherapy Followed by Adebrelimab Maintenance in Limited-Stage SCLC

NCT07200154 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025YJZ78
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, single-center phase II trial that will enroll 30 patients with limited-stage small-cell lung cancer to evaluate the safety and efficacy of adebrelimab combined with chemoradiotherapy followed by adebrelimab maintenance.

Conditions

Limited-stage Small-cell Lung Cancer; Concurrent Chemoradiation Therapy

Keywords

limited-stage small-cell lung cancer; Immune checkpoint inhibitors; Concurrent Chemoradiation Therapy

Outcome Measures

Primary Outcomes (1)

• PFS

  From subject enrollment to the first recorded disease progression or death from any cause, whichever occurs first

  through study completion, an average of 3 years

Secondary Outcomes (4)

• ORR

  through study completion, an average of 3 years

• OS

  through study completion, an average of 3 years

• DCR

  through study completion, an average of 3 years

• Adverse Events

  From the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment

Study Arms (1)

experimental group

EXPERIMENTAL

Patients meeting inclusion criteria will receive adebrelimab combined with chemotherapy followed by concurrent radiotherapy. Adebrelimab maintenance therapy will be administered until disease progression or intolerable toxicity, for a maximum duration of 2 years.

Drug: Adebrelimab with concurrent chemoradiotherapy

Interventions

Adebrelimab with concurrent chemoradiotherapy DRUG

Adebrelimab combined with chemotherapy and concurrent radiotherapy, followed by maintenance therapy with Adebrelimab until disease progression or intolerable toxicity, for up to 2 years.

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years, either sex. Histologically or cytologically confirmed limited-stage small-cell lung cancer (LS-SCLC) defined by Veterans Administration Lung Group (VALG) two-stage system.
• Availability of either an archival tumour-tissue block/slides or a newly obtained biopsy from a lesion that has not previously been irradiated.
• ≤ 2 prior cycles of chemotherapy or chemotherapy-naïve. ECOG performance-status 0 or 1. At least one measurable lesion per RECIST 1.1: ≥ 10 mm in longest diameter for non-nodal lesions or ≥ 15 mm in short axis for lymph-node lesions on CT scan.
• Estimated life expectancy ≥ 3 months. Adequate pulmonary function (as judged by the investigator).
• Adequate major organ function defined as:
• Haematology: Hb ≥ 90 g/L; ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L. Biochemistry: serum albumin ≥ 30 g/L; ALT and AST \< 3 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN.
• Women of child-bearing potential must have a negative serum or urine pregnancy test within 14 days before enrolment and must use effective contraception from screening until ≥ 8 weeks after the last study-dose; men must be surgically sterile or agree to use effective contraception during the same period.
• Voluntary informed consent signed; willing and able to comply with study procedures and follow-up.

You may not qualify if:

• Prior solid-organ, allogeneic stem-cell or planned transplantation. Immunosuppressive therapy ≤ 14 days before first adebrelimab dose (except intranasal/inhaled corticosteroids or physiological systemic doses equivalent to ≤ 10 mg/day prednisolone).
• Known hypersensitivity to etoposide, cisplatin, adebrelimab, their excipients, or severe allergic reaction to any other monoclonal antibody.
• Live-attenuated vaccine within 4 weeks before first dose or intent to receive one during the study.
• Active autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyper-/hypothyroidism).
• Uncontrolled asthma requiring bronchodilators or other systemic therapy (childhood asthma fully resolved and requiring no intervention in adulthood is allowed).
• Urinalysis ≥ ++ protein or 24-h urine protein ≥ 1.0 g. Prior malignancy except adequately treated basal-cell or squamous-cell skin carcinoma or cervical carcinoma in situ.
• HIV infection or known AIDS. Within 6 months before enrolment: myocardial infarction, severe/unstable angina, NYHA class ≥ II heart failure, poorly controlled arrhythmia (including QTcF \> 450 ms \[men\] or \> 470 ms \[women\] by Fridericia), symptomatic congestive heart failure.
• Systemic anti-infective therapy (IV antibiotics, antifungals, or antivirals) within 4 weeks before first dose, or unexplained fever \> 38.5 °C during screening or before first dose.
• Active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (anti-HCV positive and HCV-RNA detectable), or HBV/HCV co-infection.
• Participation in another interventional clinical trial within 4 weeks before first dose.
• Known history of substance abuse or recreational drug use. Any severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, could increase study-related risk or interfere with results.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Huiming Yu, MD

CONTACT

010-8819 6984; huiming740512@126.com

Leilei Jiang, MD

CONTACT

13810737828; drjiangleilei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

CN (1)