Status:
RECRUITING
Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Collaborating Sponsors:
Pfizer
Conditions:
Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single arm, open-label exploratory study conducted in resectable stage II-IIIA NSCLC without EGFR/ALK mutations, aiming to investigate feasibility, safety and efficacy of Sugemalimab in peri...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patients have voluntarily to join the study and give written informed consent for the study.
- Histologically documented, stage II-IIIA Non-Small Cell Lung Cancer (according to version 9th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated.
- Tumor should be considered resectable before study entry by a multidisciplinary team.
- ECOG Performance Status of 0 or 1
- At least 1 unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- Able to comply with study and follow-up procedures
- Major organ function For regular test results（no blood transfusion within 14 days）：
- Hemoglobin（HB）≥90g/L；
- Absolute neutrophils count（ANC）≥1.5×109/L；
- Blood platelets（PLT）≥100×109/L
- Biochemical tests results defined as follows:
- Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN) ；
- Alanine aminotransferase (ALT) and aspartate aminotransgerase AST≤2.5\*ULN,
- Creatinine（Cr）≤1.5\*ULN or Creatinine Clearance rate (CCr)≥60 ml/min; Coagulation test: INR/APTT within normal limits Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value (50%).
- The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters
- Subjects must provide fresh tissues or formalin-fixed tumor tissue samples at or the diagnosis NSCLC for mIF.
Exclusion
- 1\) All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
- 2\) Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).
- 3\) Any anti-tumor treatment within the past 5 years, including chemotherapy, radiotherapy, target therapy or other immunotherapy 4) Severe acute or chronic infections, including: hepatits B, hepatits C, HIV etc 5) Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.
- 6\) Histologically confirmed adenosquamous carcinoma 7) Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins 8) Subjects have interstitial lung disease (ILD), or a history of ILD that required corticosteroid treatment.
- 9\) Women in pregnancy or lactation. 10) Patients who are allergic to any of the agent or any ingredient
Key Trial Info
Start Date :
June 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06987734
Start Date
June 19 2025
End Date
August 31 2028
Last Update
June 26 2025
Active Locations (1)
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1
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai, Shanghai Municipality, China, 200433