Trial Title:
Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial
NCT ID:
NCT06485544
Condition:
Small Cell Lung Cancer (SCLC)
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Etoposide
Etoposide phosphate
Conditions: Keywords:
SCLC
Adebrelimab
Neoadjuvant
Chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab + Etoposide + Platinum-based Therapy
Description:
Intervention 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.
Arm group label:
Adebrelimab + Etoposide + Platinum-based Therapy
Intervention type:
Drug
Intervention name:
Etoposide + Platinum-based Therapy
Description:
Intervention 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.
Arm group label:
Etoposide + Platinum-based Therapy
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age between 18 and 75 years, inclusive, with no restriction on gender.
2. ECOG performance status of 0-1.
3. Histologically or cytologically confirmed diagnosis of small cell lung cancer
(SCLC).
4. According to the 8th edition of AJCC staging, participants must have resectable or
potentially resectable stage I-IIIB (T1-4N0-2M0) SCLC.
5. Measurable lesions (tumor lesions with a CT scan long axis ≥10 mm, lymph node
lesions with a CT scan short axis ≥10 mm).
6. Initial diagnosis of small cell lung cancer without prior treatment with radiation,
chemotherapy, traditional Chinese medicine, surgery, or targeted therapy.
7. Various imaging examinations including PET-CT, enhanced CT or ultrasound of the
chest and abdomen, MRI of the head, and bone scan confirm no metastatic lesions.
8. Participants must have sufficient cardiopulmonary function to tolerate planned lung
resection surgery.
9. No contraindications to immune checkpoint inhibitor (ICI) use based on laboratory
tests.
10. Normal organ function, as defined by the following criteria:
(1) Hematological criteria (within 14 days without blood transfusion, hematopoietic
factors, or correcting medications):
1. ANC ≥ 1.5 × 10^9/L;
2. PLT ≥ 100 × 10^9/L;
3. Hb ≥ 90 g/L; (2) Biochemical criteria:
a. TBIL ≤ 1.5 × ULN; b. ALT, AST ≤ 2.5 × ULN (if abnormal liver function due to liver
metastasis, ≤ 5 × ULN); c. Serum creatinine (sCr) ≤ 1.5 × ULN, estimated glomerular
filtration rate (eGFR) ≥ 50 mL/min (Cockcroft-Gault formula); (3) Coagulation function:
INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN. 11. Female participants of childbearing potential
must have a negative serum pregnancy test within 3 days before starting study medication
and agree to use a medically accepted method of highly effective contraception during the
study and for 3 months after the last dose of study drug (e.g., intrauterine device,
contraceptive pills, or condoms). Male participants with female partners of childbearing
potential must have undergone surgical sterilization or agree to use effective
contraception during the study and for 3 months after the last dose of study drug.
12. Participants must voluntarily consent to participate in this study, sign an informed
consent form, demonstrate good compliance, and agree to follow-up visits.
Exclusion Criteria:
1. Central nervous system metastasis.
2. 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.
3. 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.
4. 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).
5. Vaccination with live attenuated vaccines within 4 weeks before the first
administration or planned during the study period.
6. Any other malignancy within the past 3 years.
7. Evidence of past or present pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiation pneumonia, drug-induced pneumonia, or severely impaired
lung function.
8. Uncontrolled hypertension.
9. Grade II or higher myocardial ischemia or myocardial infarction, uncontrolled
arrhythmias (including QTc interval ≥450 ms for males and ≥470 ms for females).
According to NYHA standards, Class III-IV heart failure, or left ventricular
ejection fraction (LVEF) < 50% by cardiac ultrasound, myocardial infarction within 6
months before enrollment, NYHA Class II or higher heart failure, uncontrolled
angina, uncontrolled severe ventricular arrhythmias, clinically significant
pericardial disease, or electrocardiogram (ECG) indicating acute ischemia or active
conduction system abnormalities.
10. Severe infection within 4 weeks before the first administration (e.g., requiring
intravenous antibiotics, antifungals, or antivirals), or unexplained fever > 38.5°C
during screening/first administration.
11. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell
transplantation.
12. Pregnant or breastfeeding women; patients of childbearing potential unwilling or
unable to use effective contraception.
13. Known allergic reaction, hypersensitivity, or intolerance to SHR-1316, etoposide,
cisplatin, or their excipients.
14. Participation in another clinical study or less than 4 weeks since the end (last
dose) of a previous clinical study, or less than 5 half-lives of the study drug.
15. Known history of substance abuse, alcohol abuse, or drug addiction.
16. Any condition that the investigator believes may compromise the safety of the
participant or the participant's ability to meet or follow study requirements.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tangdu Hospital Affiliated to the Fourth Military Medical University
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaolong Yan, Dr
Phone:
029-847171569
Email:
yanxiaolong@fmmu.edu.cn
Start date:
July 1, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Tang-Du Hospital
Agency class:
Other
Source:
Tang-Du Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06485544
