A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: NSCLC

Treatments: Drug: SHR-1826；Adebrelimab；SHR-8068；Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06844474

SHR-1826-203

Details and patient eligibility

About

This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. ECOG performance score of 0-1.
3. Life expectancy ≥ 3 months.
4. Have at least one measurable tumor lesion per RECIST v1.1.
5. Subjects with histologically confirmed locally advanced or metastatic NSCLC.
6. Good level of organ function.
7. Provide archived or fresh tumor tissue for vendor test.

Exclusion criteria

1. Subjects with active central nervous system metastases or meningeal metastases;
2. History of serious cardiovascular and cerebrovascular diseases;
3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
4. Severe infection within 4 weeks prior to the first dose;
5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
6. Subjects with uncontrolled tumor-related pain;
7. Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
9. Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0);
10. History of immunodeficiency, including a positive HIV test;
11. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Arm A

Experimental group

Description:

SHR-1826 for injection in combination with Adebrelimab injection and SHR-8068 with or without Bevacizumab injection

Treatment:

Drug: SHR-1826；Adebrelimab；SHR-8068；Bevacizumab