Efficacy and Safety of Sacituzumab Tirumotecan Combined with Furmonertinib in Patients with Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy.
Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage Ⅳ) and not amenable to curative surgery and/or curative concurrent/sequential chemoradiotherapy [according to the 8th edition TNM staging system for lung cancer by the Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC)], with tissue or blood-based genetic testing showing EGFR-sensitive mutations (19del and L858R).
Subjects must have received prior EGFR-TKI therapy for locally advanced or metastatic disease and experienced treatment failure (documented radiographic disease progression), and must meet one of the following requirements: a) progressed after first- or second-generation EGFR-TKI, and histologically confirmed T790M-negative after treatment failure; b) progressed after third-generation EGFR-TKI regardless of T790M mutation status; and progressed after platinum-based chemotherapy or have chemotherapy intolerance.
Male or female subjects aged ≥18 years and ≤75 years who have signed the informed consent form.
ECOG performance status of 0 or 1, with an expected survival >6 months.
Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); small cell lung cancer (including combined small cell and non-small cell lung cancer); patients who have previously received systemic therapy (prior adjuvant or neoadjuvant therapy is permitted).
Patients with symptomatic brain metastases at the start of treatment (patients with previously treated brain metastases are eligible if asymptomatic brain metastases persist for at least 4 weeks while on stable dose medication).
Patients who participated in an interventional oncology clinical trial concurrently during first-line therapy or within 30 days prior to first-line therapy.
History of tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months before treatment initiation.
Single group
sacituzumab tirumotecan
DrugSacituzumab tirumotecan 5 mg/kg by intravenous infusion on Days 1 and Day 15 of each cycle; Furmonertinib mesylate 80 mg once daily.
PFS
PFS was defined as the time from the initial treatment to the first occurrence of disease progression or all-cause death (whichever occurs first ) assessed by the investigator according to RECIST v1.1.
OS
OS was defined as the time from the initial treatment until the date of death due to any cause.
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.
DCR
The percentage of patients who have achieved CR，PR and SD assessed by BIRC and investigators per RECIST v 1.1
Duration of Response (DoR)
From the date that response criteria are first met to the first occurrence of PD as determined by BIRC and investigators per RECIST v1.1 or death from any cause, whichever occurs first
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