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

NCT06844474
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
300
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Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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Start date
2025-03-07
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Number of sites
1
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Summary
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.
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Short title
A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC
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Official title
A Phase II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-1826 for Injection in Patients With NSCLC
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-02-29
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First posted
2025-02-25
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Registry last updated
2025-03-19
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Primary completion date
2026-08-31
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Start date
2025-03-07
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Participants
300
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Participant count basis
Estimated
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Planned participants
300
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Protocol amendments
0
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06844474
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ClinicalTrials.gov ID
NCT06844474
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Incidence and severity of adverse events (AEs) /serious adverse events(SAEs)

    Timeframe: approximately 2 years

  2. Overall response rate (ORR)

    Timeframe: approximately to 2 years

  1. Duration of response (DoR)

    Timeframe: approximately to 2 years

  2. Disease control rate (DCR)

    Timeframe: approximately to 2 years

  3. Progression-free survival (PFS)

    Timeframe: approximately to 2 years

  4. Overall survival (OS)

    Timeframe: approximately to 5 years after last subject enrolled

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
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  • Chinese People's Liberation Army (PLA) General HospitalBeijing, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)