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

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that is difficult to treat. The researchers want to see how well a combination of three medications—SHR-A1921, Adebrelimab, and SHR-8068, with or without carboplatin—works for patients who cannot have surgery or certain types of radiation therapy. The goal is to find out if this combination is safe and effective in helping to manage the cancer.

To participate in this trial, you need to be between 18 and 75 years old and have been diagnosed with advanced NSCLC that cannot be surgically removed. You should also have at least one measurable tumor, and your overall health must be stable. If you join, you’ll need to sign a consent form and attend follow-up appointments to monitor your health and how you’re responding to the treatment. It’s important to note that some people may not be eligible, such as those with certain heart issues, untreated brain metastases, or previous treatments that could interfere with this study. If you’re interested and meet the criteria, this may be an opportunity to contribute to research that could help improve future cancer treatments.

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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;