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
Qualifiers
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
Treatments tested in this trial
- Adebrelimab + Etoposide + Platinum-based Therapy
- Etoposide + Platinum-based Therapy
Treatment groups
104 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov