Non-small cell lung cancer
Conditions
Interventions
Experimental group:Patients receive one intravenous dose of Sacituzumab tirumotecan 4 mg/kg plus toripalimab 3 mg/kg every 2 weeks for a total of 4 cycles.
Sponsors
The General Hospital of the Eastern Theater Command of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participated in clinical research; Fully understand and informed the study and sign the informed consent form (ICF); Be willing to follow and be able to complete all trial procedures; 2. Male or female subjects aged 18-75 years old (including the cut-off) at the time of signing the ICF; 3. Confirm negative for epidermal growth factor receptor (EGFR) sensitive mutations, anaplastic lymphoma kinase (ALK), or proto-oncogene tyrosine protein kinase ROS (ROS1) rearrangement; 4. Histologically or cytologically confirmed stage IIIA-IIIB (N2) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM staging of lung cancer), which can tolerate complete resection of lung cancer; 5. No previous systemic treatment; 6. At least one measurable target lesion, as assessed by the investigator according to RECIST v1.1, within 4 weeks before the first dose; Patients must provide eligible tumor tissue for PD-L1 (Dako 22C3) and TROP2 IHC testing; 8. ECOG PS score of 0-1; 9. Expected survival time >=12 weeks; 10. Both hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) are negative. If HBsAg was positive or HBcAb was positive, hepatitis B virus DNA (HBV-DNA) had to be less than 2500 copies per milliliter or 500 IU per milliliter. Subjects with negative HCV antibody or negative HCV-RNA were eligible for enrollment. If HCV-RNA is positive, subjects must have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3×ULN to be enrolled. Subjects with co-infection of hepatitis B and C (positive for HBsAg or HBcAb and positive for anti-HCV) were excluded. 11. Good vital organ function, defined as no blood transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) therapy within 14 days before the first dose of this study; 12. Female subjects must have a negative serum pregnancy test within 3 days before treatment, and agree to take effective contraceptive measures during and after treatment for 6 months, and refrain from breastfeeding during treatment; Male patients had to consent to use contraception during treatment. 13. Male patients had to: agree to abstain from sex (avoid heterosexual intercourse) or to use contraception as follows: if the partner was a woman of reproductive age or was pregnant, male patients had to either abstain from sex or use condoms to prevent embryonic exposure to the drug during the study treatment and for at least 6 months after the last dose of the study drug. Regular abstinence (e.g., calendar day, ovulation, basal body temperature, or postovulatory contraception) and in vitro ejaculation are ineligible methods of contraception.
Exclusion criteria
Exclusion criteria: 1. Other histopathological types of non-small cell lung cancer (NSCLC), including squamous cell carcinoma mixed with adenocarcinoma, NSCLC with components of small cell lung cancer and neuroendocrine carcinoma; 2. Patients with EGFR sensitizing mutations or ALK or ROS1 gene rearrangements; 3. Known allergy to the study drug or any of its components; 4. Subjects with known central nervous system (CNS) metastases with leptomeningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or no local treatment. Patients with brain metastases who had received local treatment were allowed if they had been clinically stable for at least 4 weeks before treatment and were free from the use of glucocorticoids or anticonvulsants for at least 14 days. 5. Any active infection requiring systemic anti-infective therapy within 14 days before the first dose or a positive RT-PCR test for COVID-19 infection during the screening period. Subjects with a history of COVID-19 infection had to have a negative RT-PCR test before the first dose. 6. Myocardial infarction with uncontrolled arrhythmias (including QTc interval >=450 msec in men or >=470 msec in women) within 6 months before the first dose (QTc interval calculated with Fridericia's formula); Or grade III-IV cardiac dysfunction according to the New York Heart Association (NYHA) standard or left ventricular ejection fraction 1.5 mmol/L ionized calcium or calcium >12 mg/dL or corrected serum calcium >ULN); 8. Subjects with interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe pulmonary function impairment in the past or during screening, which may interfere with the detection and treatment of suspected drug-related pulmonary toxicity according to the investigator's judgment; 9. Patients with hepatitis B [hepatitis B surface antigen (HBsAg) positive and detection of HBV-DNA suggesting viral replication]; Or patients with hepatitis C (positive for hepatitis C virus (HCV) antibody and detection of HCV-RNA suggesting viral replication); Or syphilis screening positive (except specific antibody test positive, nonspecific antibody test negative and clinical judgment confirmed as inactive infection); Or a known history of human immunodeficiency virus (HIV) positivity or screening positive for HIV; 10. The subject has a known active or suspected autoimmune disease. Subjects who were in a stable state and did not require systemic immunosuppressive therapy were allowed to enroll. 11. Other active malignancies within 5 years or at the same time. Localized tumors that had been cured for more than 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, were eligible for inclusion. 12. Persons who received live or attenuated vaccine within 28 days before the first dose or who have plans to receive such vaccine during the study period; However, inactivated virus vaccines for seasonal influenza are permitted; 13. Received radical radiotherapy within 3 months before the first dose; 14. Subjects had previously received Trop2-targeted therapy or topoisomerase I inhibitor therapy, or had been previously treated with anti-PD-1, anti-PD-L1, anti-PD-L-2, or anti-CTLA-4 antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission rate, MPR;Event-free survival period;Overall survival ; | — |
Countries
China
Contacts
Public ContactTangfeng Lv
The General Hospital of the Eastern Theater Command of the People's Liberation Army of China
Outcome results
None listed