Status:
NOT_YET_RECRUITING
This is a Two-cohort, Exploratory Clinical Study Assessing the Activity of Benmelstobart Combined With Chemotherapy With or Without Anlotinib in Resectable Limited-Stage Small Cell Lung Cancer
Lead Sponsor:
Tang-Du Hospital
Conditions:
Limited Stage Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A total of 66 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 33 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined wit...
Eligibility Criteria
Inclusion
- Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
- Aged 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
- Histologically confirmed small cell lung cancer (SCLC).
- Confirmed as stage I-IIIB SCLC (T1-3N0-2M0) per AJCC 9th Edition.
- Patients who have received 1 cycle of chemotherapy are eligible; no other prior treatments are permitted.
- ECOG Performance Status (PS) 0 or 1.
- Assessed by the investigator as having no surgical contraindications.
- At least one measurable lesion per RECIST 1.1 criteria.
- Expected survival ≥8 weeks.
- Women of childbearing potential (aged 15-49) must have a negative serum pregnancy test within 7 days before treatment initiation and agree to use reliable contraception during the study until 8 weeks after discontinuation. Normal function of major organs meeting the following criteria:
- Hematologic tests (no blood transfusion, blood products, G-CSF, or hematopoietic stimulants within 14 days): Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelets (PLT) ≥80×10⁹/L.
- Biochemical tests meeting: Total bilirubin (TBIL) ≤1.5×ULN; ALT/AST ≤2.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60 mL/min.
- Urine protein \<2+; for patients not on anticoagulation: INR ≤1.5, APTT ≤1.5×ULN. Patients on full-dose or parenteral anticoagulants may enroll if dosing has been stable for ≥2 weeks and coagulation tests are within therapeutic ranges.
Exclusion
- Histologically confirmed mixed-type SCLC.
- Extensive-stage SCLC.
- ECOG PS \>1.
- Active or untreated CNS metastases confirmed by CT/MRI during screening/prior imaging.
- Uncontrolled tumor-related pain.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage (≥1×/month).
- Uncontrolled/symptomatic hypercalcemia (ionized calcium \>1.5 mmol/L, calcium \>12 mg/dL, or corrected serum calcium \>ULN).
- Systemic immunostimulants (e.g., IFN-α, IL-2, TNF) within 4 weeks prior to enrollment (cancer vaccines allowed if prior).
- Systemic corticosteroids (\>10 mg prednisone/day or equivalent) or immunosuppressants within 14 days, except: Replacement therapy (≤10 mg prednisone/day); Topical/ocular/intra-articular/nasal/inhaled steroids with minimal systemic absorption; Short-term (≤7 days) prophylactic use (e.g., contrast allergy) or for non-autoimmune conditions.
- Imaging-confirmed tumor invasion of major vessels or high risk of fatal hemorrhage per investigator; or cavitary/necrotic lung tumors.
- Other malignancies within 5 years except: cervical CIS, cured basal cell carcinoma, Ta/Tis bladder tumors.
- Prior use of anlotinib or other antiangiogenic agents.
- Prior anti-PD-1/PD-L1/CTLA-4 antibodies or other T-cell co-stimulation/checkpoint pathway therapies (e.g., ICOS, CD40/CD137/GITR/OX40 agonists).
- Hypersensitivity to anlotinib or benmelstobart components.
- Factors impairing oral drug intake (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- Uncontrolled comorbidities including:
- Poorly controlled hypertension (SBP ≥150 mmHg, DBP ≥100 mmHg);
- Grade ≥1 myocardial ischemia/infarction, arrhythmias (QTc ≥480 ms), or ≥NYHA Class II heart failure;
- Abnormal coagulation (INR \>1.5, PT \>ULN+4s, APTT \>1.5×ULN), bleeding tendency, or thrombolytic/anticoagulant therapy (prophylactic low-dose heparin \[6,000-12,000 U/day\] or aspirin \[≤100 mg/day\] allowed if INR ≤1.5);
- Active/severe uncontrolled infections;
- Cirrhosis, decompensated liver disease, active/chronic hepatitis requiring antivirals;
- Renal failure requiring dialysis;
- Immunodeficiency (HIV+, congenital/acquired immunodeficiency) or organ transplant history;
- Poorly controlled diabetes (FBG \>10 mmol/L);
- Urine protein ≥++ or 24-h urine protein \>1.0 g;
- Epilepsy requiring treatment;
- Non-healing wounds/fractures.
- Significant hemoptysis (\>50 mL/day within 2 weeks) or clinically significant bleeding (e.g., GI bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++).
- Interstitial lung disease (ILD), drug-induced ILD, steroid-requiring radiation pneumonitis, or active ILD.
- Arterial/venous thromboembolism within 6 months (e.g., stroke \[including TIA\], DVT, PE).
- Grade ≥2 peripheral neuropathy (excluding trauma-related).
- Major surgery/severe trauma with residual effects within 14 days.
- Concurrent clinical trials or \<4 weeks from prior trial treatment.
- Live/attenuated vaccination within 30 days before benmelstobart or planned during study.
- History of severe hypersensitivity to monoclonal antibodies.
- Pregnant/lactating women.
- Uncontrolled psychiatric/neurological disorders affecting compliance.
- Other factors per investigator judgment that may lead to study termination (e.g., severe illness, lab abnormalities, or social/family constraints compromising safety/data collection).
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06978153
Start Date
May 20 2025
End Date
November 1 2027
Last Update
May 18 2025
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