NSCLC (Advanced Non-small Cell Lung Cancer)
Conditions
Brief summary
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.
Interventions
DRUGSCTB41
SCTB41 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle
DRUGdocetaxel
docetaxel is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle
Sponsors
Sinocelltech Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse events (AEs) | 24 months | To investigate the safety characteristics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 2 years | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. |
| Disease control rate (DCR) | Up to 2 years | The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1. |
| Progression-free survival (PFS) | Up to 2 years | The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first. |
| Overall survival (OS) | Up to 2 years | Overall survival is defined as the time from the start of treatment until death due to any cause. |
Countries
China
Outcome results
None listed