Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC

Suzhou Suncadia Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Advanced Non-small Cell Lung Cancer

Treatments: Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06434103

SHR-A1921-205

Details and patient eligibility

About

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

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin

Experimental group

Treatment:

Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin