WithdrawnPhase 1/2

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

Stopped: Sponsor's Strategy Adjustment

0Started 2024-10-10

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
✓. Aged 18-75 at the time of signing the informed consent;
✓. 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;
✓. At least one measurable lesion consistent with RECIST v1.1;
✓. ECOG PS score: 0-1;
✓. The organ function level is good;

Exclusion criteria

✕. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
✕. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
✕. Previous or co-existing malignant neoplasms;
✕. The presence of any active or known autoimmune disease;
✕. Have clinical symptoms or diseases of the heart that are not well controlled;
✕. People with past or current interstitial pneumonia/interstitial lung disease;
✕. Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies;
✕. 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;

What they're measuring

DLT

Timeframe: 21 days after the first dose

ORR based on RECIST v1.1 assessment.

Timeframe: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years

Trial details

NCT IDNCT06434103

SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-10

View on ClinicalTrials.gov More Advanced Non-small Cell Lung Cancer trials