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Trial Title:
PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC
NCT ID:
NCT06375109
Condition:
Limited-stage Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
administered via Intravenous (IV) injection
Arm group label:
neoCIT
Intervention type:
Drug
Intervention name:
Carboplatin injection
Description:
administered via IV injection
Arm group label:
neoCIT
Arm group label:
neoCT
Intervention type:
Drug
Intervention name:
Cisplatin injection
Description:
administered via IV injection
Arm group label:
neoCIT
Arm group label:
neoCT
Intervention type:
Drug
Intervention name:
Etoposide injection
Description:
administered via IV injection
Arm group label:
neoCIT
Arm group label:
neoCT
Summary:
This is an open-label, non-randomized, controlled, single-center, phase II study to
compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy
(carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide)
alone followed by radical surgery and adjuvant treatment as perioperative therapy in
patients with limited-stage SCLC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients voluntarily participated in this study, signed an informed consent form,
and demonstrated good compliance.
2. They were histologically or cytologically confirmed with limited-stage small-cell
lung cancer (TNM stage; T1-3N0-2M0).
3. The age range was 18 to 75 years, with no gender restriction.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.
5. Life expectancy was estimated to be at least 3 months.
6. No previous anti-tumor treatment specifically for SCLC was administered.
7. According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
criteria, there must be at least one measurable lesion.
8. Patients' organ functions must be adequately sufficient, with the following
requirements to be met before the first study treatment:
1. Hematological parameters: ANC ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin
≥90g/L.
2. Renal function: serum creatinine ≤1.5 times the upper limit, or creatinine
clearance ≥50 mL/min.
3. Liver function: ALT/AST ≤2.5 times the upper limit, total serum bilirubin ≤2
times the upper limit.
4. Coagulation: INR should be ≤ 1.5 times the upper limit.
9. Patients of childbearing potential must agree to use contraception.
10. Patients must be able to tolerate chemotherapy, immunotherapy, and surgery.
Exclusion Criteria:
1. Patients who have received anti-tumor treatment for SCLC (including but not limited
to chemotherapy and radiation therapy at the site of the lesion).
2. Patients who have previously used immune checkpoint inhibitors such as PD-1/PD-L1
inhibitors for treatment.
3. Patients with a history of interstitial lung disease, non-infectious pneumonia, or
uncontrollable systemic diseases, including pulmonary fibrosis and acute lung
disease.
4. Patients requiring systemic anti-bacterial, anti-fungal, or anti-viral treatment for
severe chronic or active infections, including tuberculosis.
5. Patients known to have HIV.
6. Patients with active hepatitis B or hepatitis C.
7. Patients with active autoimmune diseases or a history of autoimmune diseases that
may recur.
8. Patients with diseases requiring systemic corticosteroid treatment or other
immunosuppressive therapy.
9. Patients deemed by the investigator to have concomitant diseases that pose a serious
risk to patient safety or could affect the patient's ability to complete the study.
10. Patients who have undergone major surgery within 4 weeks prior to treatment
initiation, or those with significant trauma or fractures, or those with unhealed
wounds at the time of treatment.
11. Patients with severe cardiac diseases, such as NYHA class III or higher congestive
heart failure, CCS class III or higher angina, a history of myocardial infarction in
the past 6 months, or arrhythmias requiring medication.
12. Patients with comorbidities that make them unsuitable for surgery.
13. Patients who have had an allergic reaction to the study drug or excipients in the
medication.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 16, 2024
Completion date:
April 15, 2029
Lead sponsor:
Agency:
Beijing Chest Hospital, Capital Medical University
Agency class:
Other
Source:
Beijing Chest Hospital, Capital Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06375109
