Shanghai Pulmonary Hospital, Shanghai, China
Shanghai, Shanghai Municipality, 200433, China
Location status: Recruiting
NCT Number: NCT06987734
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 perioperative contexts. Twenty-five resectable stage II-IIIA patients are planned to be enrolled. The proportion of patients with squamous cell carcinoma will not less than 40%.
Combined neoadjuvant chemotherapy and immunotherapy with fixed dose of Sugemalimab 1200 mg IV Q3W + Platinum-based chemo in resectable stage II-IIIA NSCLC adult patients followed by surgery. After completion of neoadjuvant therapy (3-4 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression in neoadjuvant therapy. Pathological response is planned to assessed after surgery. Following surgery, the patients with complete resection will receive an additional 1 year of Sugemalimab q3w. Treatment will commence as soon as clinically feasible post-surgery.
Informed consent will be obtained prior to tissue collection and genome sequencing for each participant. Primary tumour tissue will be obtained at diagnosis by biopsy such as percutaneous lung puncture biopsy, bronchoscopic biopsy or endobronchial ultrasound (EBUS) (based on clinical practice). Fresh tumour tissue was collected after surgical resection. Tissues collected were subjected to medically necessary pathology for diagnosis. Specimens were processed for multiplex immunofluorescence, single-cell sequencing and spatial transcriptomics, bulk RNAseq and WES to explore the changes in the immune microenvironment before and after suglizumab administration.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200433, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Biochemical tests results defined as follows:
Exclusion criteria
Patients will receive 3-4 cycles of neoadjuvant treatment with preoperative suglizumab in combination with chemotherapy, followed by surgery. After surgery, patients will receive 1-4 cycles of platinum-containing adjuvant chemotherapy,followed by 1 year of adjuvant sugemalimab.
Time frame: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy
Major Pathological Response (≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes)
Time frame: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy
0% residual viable tumor cells in the primary tumor and sampled lymph nodes
Time frame: 6 /12 /18 months
Event-free survival rate at 6 /12 /18 months
Time frame: Perioperative
Specimens were processed for multiplex immunofluorescence, single-cell sequencing and spatial transcriptomics, bulk RNAseq and WES to explore the changes in the immune microenvironment before and after suglizumab administration.
Contact information is provided by the study sponsor or research team.
jiale wang Wang
CONTACT
shengxiang ren Ren, Pro.
CONTACT
Shanghai Pulmonary Hospital, Shanghai, China
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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