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

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434103
• Other study ID #: SHR-A1921-205
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 2024
• Est. completion date: March 2027

Study information

• Verified date: May 2024
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Mengbo Zhao
• Phone: 0518-82342973
• Email: mengbo.zhao[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: March 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• SHR-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT		21 days after the first dose
Primary	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	Adverse event		All informed subjects signed informed consent from the beginning to the end of the safety follow-up period, up to 2 years
Secondary	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