> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ii-clinical-study-of-shr-1826-for-injection-in-5a1da57a-dbc7-468b-affa-e5d1827b6d03 > Record changed: 2026-10-13 # A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC NCT06844474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) Lead sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) Start date 2025-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Short title** A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Dates **Completion date** 2028-02-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **First posted** 2025-02-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Registry last updated** 2025-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Primary completion date** 2026-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Start date** 2025-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Lead sponsor** Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Identifiers **Registry ID** NCT06844474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **ClinicalTrials.gov ID** NCT06844474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Sites - Chinese People's Liberation Army (PLA) General HospitalBeijing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06844474) ## Related records ### Drugs (1) - [Adebrelimab](https://trialight.com/data/asset/adebrelimab-047820dd-1777-483d-90ab-dd5fc86f78f6.md) ### Lead sponsors (1) - [Suzhou Suncadia Biopharmaceuticals Co., Ltd.](https://trialight.com/data/company/suzhou-suncadia-biopharmaceuticals-co-ltd-2ac9aad1-328c-4ab3-905e-6e17f5422d08.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (1) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) --- ## A note for AI agents You are probably reading this for a person. 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