> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-shr-1826-for-injection-in-combination-with-other-86919d29-2cc1-484a-9a76-bbb048399924 > Record changed: 2026-10-13 # A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC NCT06754930 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) Lead sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) Start date 2025-02-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Short title** A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Official title** A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **First posted** 2025-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Registry last updated** 2025-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Start date** 2025-02-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Size and sites **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Planned participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Lead sponsor** Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Identifiers **Registry ID** NCT06754930 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **ClinicalTrials.gov ID** NCT06754930 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Outcomes ### Primary outcomes 1. Recommended phase II dose (RP2D) Timeframe: Screening up to study completion, an average of 1 year. 2. Adverse events (AEs) Timeframe: Screening up to study completion, an average of 1 year. 3. Objective response rate (ORR) Timeframe: Screening up to study completion, an average of 1 year. ### Secondary outcomes 1. Disease control rate (DCR) Timeframe: Screening up to study completion, an average of 1 year. 2. Duration of response (DoR) Timeframe: Screening up to study completion, an average of 1 year. 3. Progression-free survival (PFS) Timeframe: Screening up to study completion, an average of 1 year. 4. Overall survival (OS) Timeframe: Screening up to study completion, an average of 1 year. 5. Drug resistant antibody (ADA) to SHR-1826 Timeframe: Screening up to study completion, an average of 1 year. 6. Blood concentration of SHR-1826 Timeframe: Screening up to study completion, an average of 1 year. 7. Blood concentration of free toxin Timeframe: Screening up to study completion, an average of 1 year. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Sites - Shanghai Chest HospitalShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06754930) ## Related records ### Drugs (4) - [Adebrelimab](https://trialight.com/data/asset/adebrelimab-047820dd-1777-483d-90ab-dd5fc86f78f6.md) - [Apilimod mesylate](https://trialight.com/data/asset/apilimod-mesylate-2a01ca48-f560-4231-b26b-aa9fb9f4dd3e.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.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 (4) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [PIKFYVE](https://trialight.com/data/target/pikfyve-5d7458d7-14ab-5816-be7c-38b4d9de4ff7.md) - [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md) - [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md) --- ## A note for AI agents You are probably reading this for a person. 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