This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of neoadjuvant therapy of sacituzumab tirumotecan combined with toripalimab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
1. Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, on Day 1 of each cycle. 2. Toripalimab will be administered at a dose of 240 mg via intravenous infusion, with a treatment cycle of every 3 weeks, on Day 1 of each cycle.
Pathological Complete Response (pCR) Rate
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatmen
Overall Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 before surgery.
Time frame: Up to Study Week 15 (before surgery)
Radiological downstaging rate
The proportion of patients with radiological T, N, and overall stage reduction (AJCC v9) compared to baseline after neoadjuvant therapy.
Time frame: Up to Study Week 15 (before surgery)
Major Pathological Response (mPR) Rate
mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Event Free Survival (EFS)
EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 2 years
Dongsheng Yue Tianjin Medical University Cancer Institute and Hospital
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall Survival (OS)
OS is defined as the time from randomization until death from any cause.
Time frame: Up to approximately 2 years
Number of participants experiencing treatment-emergent adverse events (TEAEs)
An AE was defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug. The number of participants who experienced an AE is presented.
Time frame: Up to approximately 2 years
Change From Baseline in Neoadjuvant and Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items.
Time frame: Baseline, during the neoadjuvant phase (Cycle 3), during the adjuvant phase (Cycles 1, 3, 5, and 7), and during safety follow-up visits (up to 2 years)