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Trial Title:
Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
NCT ID:
NCT06434103
Condition:
Advanced Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carboplatin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1921；Adebrelimab；SHR-8068；carboplatin
Description:
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.
Arm group label:
SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin
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
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06434103
