A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC

NCT ID: NCT06754930

Last Updated: 2025-04-17

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

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-18

Study Completion Date

2027-12-31

Brief Summary

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This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer (NSCLC)

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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Experimental group

Group Type EXPERIMENTAL

SHR-1826

Intervention Type DRUG

SHR-1826 for injection.

SHR-1316

Intervention Type DRUG

SHR-1316 for injection.

SHR-9839

Intervention Type DRUG

SHR-9839 for injection.

SHR-8068

Intervention Type DRUG

SHR-8068 for injection.

Ametinib mesylate

Intervention Type DRUG

Ametinib mesylate.

BP-102

Intervention Type DRUG

BP-102 for injection.

Carboplatin

Intervention Type DRUG

Carboplatin for injection.

Interventions

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SHR-1826

SHR-1826 for injection.

Intervention Type DRUG

SHR-1316

SHR-1316 for injection.

Intervention Type DRUG

SHR-9839

SHR-9839 for injection.

Intervention Type DRUG

SHR-8068

SHR-8068 for injection.

Intervention Type DRUG

Ametinib mesylate

Ametinib mesylate.

Intervention Type DRUG

BP-102

BP-102 for injection.

Intervention Type DRUG

Carboplatin

Carboplatin for injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Voluntary participation and written informed consent.
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed NSCLC.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate organ function.
9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion Criteria

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
2. Previous or co-existing malignancies.
3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
4. Uncontrollable tumor-related pain.
5. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
7. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy.
8. With poorly controlled or severe cardiovascular disease.
9. Active hepatitis B and hepatitis C.
10. Patients with a history of immunodeficiency.
11. Severe infection 30 days before the first dose.
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

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yijun Jia

Role: CONTACT

+86-18801784695

Tingting Lei

Role: CONTACT

+86-18610051325

Facility Contacts

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Shun Lu

Role: primary

+86-13601813062

Other Identifiers

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SHR-1826-201-LC

Identifier Type: -

Identifier Source: org_study_id

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