Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial
ConditionSmall Cell Lung Cancer (SCLC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital
About this trial
This study is a randomized, open-label, multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy (etoposide and platinum-based therapy) as neoadjuvant treatment for resectable stage I-IIIB (stage IIIB limited to T1-4N1-2M0) small cell lung cancer (SCLC). The study is primarily conducted at Tangdu Hospital of the Fourth Military Medical University. A total of 104 patients with stage IA-IIIB SCLC (stage IIIB limited to T1-4N1-2M0) will be enrolled and randomized 1:1 to receive either Adebrelimab plus chemotherapy or chemotherapy alone. Each patient will undergo 3 cycles of study treatment followed by a 3-4 week break before surgery. Treatment will be discontinued if patients experience disease progression, intolerable drug-related adverse events, withdrawal of informed consent, or other specified conditions during the study. Effectiveness and safety outcomes will be monitored throughout the trial. The primary objective is to evaluate pathological complete response (pCR) with Adebrelimab combination therapy. Secondary objectives include assessing event-free survival (EFS), major pathological response (mPR), objective response rate (ORR), disease-free survival (DFS), and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years, inclusive, with no restriction on gender.
ECOG performance status of 0-1.
Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC).
According to the 8th edition of AJCC staging, participants must have resectable or potentially resectable stage I-IIIB (T1-4N0-2M0) SCLC.
Disqualifiers
Central nervous system metastasis.
History of any active autoimmune disease or autoimmune disease (including but not limited to moderate or severe interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [patients controlled by hormone replacement therapy may be included]); patients with vitiligo or childhood asthma completely resolved without adult intervention may be included; patients requiring bronchodilators for medical intervention are excluded.
Congenital or acquired immunodeficiency, such as HIV infection, active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection by analytical methods), or co-infection of hepatitis B and C, active pulmonary tuberculosis.
Use of immunosuppressive drugs within 14 days prior to the first administration of the study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg/day of prednisone or its equivalent).
Trial design
Design model
Parallel
Treatments tested in this trial
Adebrelimab + Etoposide + Platinum-based Therapy
DrugIntervention Description for Treatment Group: This intervention includes Adebrelimab in combination with Etoposide and Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Adebrelimab is administered intravenously at a fixed dose of 1200 mg over 30 minutes on Day 1 of each 3-week cycle, followed by Etoposide at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment.
Etoposide + Platinum-based Therapy
DrugIntervention Description for Control Group: This intervention includes Etoposide in combination with Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Etoposide is administered at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each 3-week cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Adebrelimab + Etoposide + Platinum-based TherapyExperimental treatment 1 intervention
Group B: Etoposide + Platinum-based TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pathological complete response rate(pCR)
Pathologic complete response (pCR), defined as the absence of tumor cells in all specimens (ypT0N0) .
Time frame
7 days after surgery.Secondary outcomes
1
Event-free survival (EFS)
The length of time after primary treatment for a cancer ends that the patient remains free of certain complicationsor events that the treatment was intended toprevent or delay.
Time frame
Long term follow-up will continue until preoperative progression, postoperative recurrence, or death from any cause at least two years.2
Major pathologic response (MPR)
MPR is defned as less than 10% residual viable tumor after neoadjuvant therapy.
Time frame
7 days after surgery.3
Objective response rate (ORR)
Per Response Evaluation Criteria in Solid Tumorsersion 1.1(REClST 1.1) using Investigator assessments, is defneas the number (%) of patients with responseof Complete Response or Partial Response.
Time frame
7 days before surgery4
Disease-free survival(DFS)
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
Time frame
Long term follow-up will continue until the death of the subiect or the end of the studv. at least two yearsSponsors and contacts
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Source ClinicalTrials.gov