A Clinical Study of SCTB41 Combined With Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer（Phase II Study Ongoing）

A Phase II/III Study of SCTB41 Plus Docetaxel vs Placebo Plus Docetaxel in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.

Inclusion Criteria:

1. Voluntarily sign the informed consent form (ICF);
2. ECOG 0-1;
3. Survival duration more than 3 months;
4. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent/sequential chemoradiotherapy;
5. Without AGA: Have experienced disease progression during or after prior treatment with PD-(L)1 inhibitors and chemotherapy.With AGA: Must have received adequate targeted therapy; EGFR-positive patients must have received prior treatment with PD-(L)1/VEGF bispecific antibody and/or TROP-2 ADC;
6. At least one measurable non-brain lesion according to RECIST v1.1;
7. Adequate major organ function.

Exclusion Criteria:

1. Histologically or cytologically confirmed presence of small cell carcinoma components;
2. Prior treatment with docetaxel;
3. Symptomatic central nervous system (CNS) metastases;
4. Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug;
5. Imaging findings at screening show tumor invasion into major blood vessels or surrounding vital organs, or the presence of a risk of esophagotracheal or esophagopleural fistula, which the investigator assesses as unsuitable for enrollment;
6. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension despite medical therapy;
7. Presence of any active autoimmune disease or history of autoimmune disease with anticipated risk of relapse;
8. Bleeding tendency, high risk of bleeding, or coagulation disorders;
9. Diagnosis of another malignancy;
10. Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose;
11. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
12. History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease;
13. Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
14. Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody;
15. Pregnant or breastfeeding women;
16. Any other condition that the investigator considers inappropriate for enrollment.