Advanced Non-small Cell Lung Cancer
Conditions
Brief summary
A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer
Interventions
DRUGSHR-A1921；Adebrelimab；SHR-8068；carboplatin
SHR-A1921:Specified dose on specified days. SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Carboplatin:Specified dose on specified days.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up; 2. Aged 18-75 at the time of signing the informed consent; 3. Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy; 4. At least one measurable lesion consistent with RECIST v1.1; 5. ECOG PS score: 0-1; 6. The organ function level is good;
Exclusion criteria
1. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.; 2. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms; 3. Previous or co-existing malignant neoplasms; 4. The presence of any active or known autoimmune disease; 5. Have clinical symptoms or diseases of the heart that are not well controlled; 6. People with past or current interstitial pneumonia/interstitial lung disease; 7. Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies; 8. Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT | 21 days after the first dose |
| ORR based on RECIST v1.1 assessment. | All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event | All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years |
| DCR based on RECIST v1.1 assessment | All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years |
Outcome results
None listed