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

NCT ID: NCT06434103

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2027-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Advanced Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

SHR-A1921;Adebrelimab;SHR-8068;carboplatin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Mengbo Zhao

Role: CONTACT

0518-82342973

Ze Zhang

Role: CONTACT

0518-82342973

Other Identifiers

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SHR-A1921-205

Identifier Type: -

Identifier Source: org_study_id

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