> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/an-open-multicenter-phase-ii-clinical-trial-of-shr-a2009-84c8c913-7888-43a8-9e22-091d472113de > Record changed: 2026-11-04 # An Open, Multicenter Phase II Clinical Trial of SHR-A2009 Combined With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer. NCT07863167 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) Participants 660 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) Lead sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) Start date 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Title and summary **Summary** The study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined with other anti-tumor therapies for perioperative treatment of resectable non-small cell lung cancer in adults. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Short title** An Open, Multicenter Phase II Clinical Trial of SHR-A2009 Combined With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Official title** An Open, Multicenter Phase II Clinical Trial of SHR-A2009 Combined With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Dates **Completion date** 2030-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **First posted** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Registry last updated** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Primary completion date** 2028-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Start date** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Size and sites **Participants** 660 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Planned participants** 660 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Lead sponsor** Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Identifiers **Registry ID** NCT07863167 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **ClinicalTrials.gov ID** NCT07863167 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Outcomes ### Primary outcomes 1. Part A1 : pCR rate; Timeframe: about 24 months 2. Part A2 : 2-year DFS rate; Timeframe: about 24 months 3. Part A3 : pCR rate and 18-month EFS rate; Timeframe: about 18 months 4. Part B1 : 2-year DFS rate. Timeframe: about 24 months 5. Part B2 : MPR rate. Timeframe: about 24 months ### Secondary outcomes 1. The incidence and grade of adverse events; Timeframe: about 48 months 2. surgical complications; Timeframe: about 24 months 3. EFS Timeframe: about 24 months ; 4. ORR; Timeframe: about 24 months 5. DFS and DFS rates; Timeframe: about 24 months 6. OS ; Timeframe: about 48 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **Healthy volunteers** No ### Inclusion criteria 1. voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ; 2. At the time of signing the informed consent form, the age is 18-70 years old ( including both ends ), both men and women can. 3. The ECOG score was 0 or 1. 4. Pathologically confirmed NSCLC, assessed as resectable or previously resected (R0). 5. Adequate bone marrow and organ function. ### Exclusion criteria 1. Participants who received systemic immunostimulatory therapy within 4 weeks prior to the first dose. 2. Participants who received systemic immunosuppressive therapy within 2 weeks before the first dose. 3. Participants with active, known or suspected autoimmune diseases. 4. Other malignant tumors within 5 years before screening. 5. Participants with a history of interstitial pneumonia or cannot exclude interstitial pneumonia; or there are other moderate to severe lung diseases that may affect respiratory function. Or received previous pneumonectomy surgery. 6. Participants with severe cardiovascular and cerebrovascular diseases. 7. There were clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first administration. 8. Arterial and venous thrombosis events occurred within 3 months before the first administration. 9. HIV test positive. 10. Participants with active hepatitis B or C. 1.Evidence of active tuberculosis infection within 1 year before the first administration. 12.Severe infection occurred within 4 weeks before the first administration. 13.History of severe allergic reactions to other monoclonal antibody / fusion protein drugs. 14\. Allergy to any component of the treatment regimen. 15.Participants were known to have a history of psychotropic drug abuse, alcohol abuse or drug abuse. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Sites - Guangdong Provincial People's HospitalGuangzhou, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07863167) ## Related records ### Drugs (2) - [Adebrelimab](https://trialight.com/data/asset/adebrelimab-047820dd-1777-483d-90ab-dd5fc86f78f6.md) - [Aumolertinib](https://trialight.com/data/asset/aumolertinib-1339ec2f-ba43-4359-aaa7-6a9516518faa.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 (2) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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