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.
- 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.
- 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.
- 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.
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2030-12-30
- First posted
- 2026-10-07
- Registry last updated
- 2026-10-07
- Primary completion date
- 2028-12-30
- Start date
- 2026-10-30
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07863167
- ClinicalTrials.gov ID
- NCT07863167
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Part A1 : pCR rate;
Timeframe: about 24 months
Part A2 : 2-year DFS rate;
Timeframe: about 24 months
Part A3 : pCR rate and 18-month EFS rate;
Timeframe: about 18 months
Part B1 : 2-year DFS rate.
Timeframe: about 24 months
Part B2 : MPR rate.
Timeframe: about 24 months
The incidence and grade of adverse events;
Timeframe: about 48 months
surgical complications;
Timeframe: about 24 months
EFS
Timeframe: about 24 months ;
ORR;
Timeframe: about 24 months
DFS and DFS rates;
Timeframe: about 24 months
OS ;
Timeframe: about 48 months
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Healthy volunteers
- No
- voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ;
- At the time of signing the informed consent form, the age is 18-70 years old ( including both ends ), both men and women can.
- The ECOG score was 0 or 1.
- Pathologically confirmed NSCLC, assessed as resectable or previously resected (R0).
- Adequate bone marrow and organ function.
- Participants who received systemic immunostimulatory therapy within 4 weeks prior to the first dose.
- Participants who received systemic immunosuppressive therapy within 2 weeks before the first dose.
- Participants with active, known or suspected autoimmune diseases.
- Other malignant tumors within 5 years before screening.
- 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.
- Participants with severe cardiovascular and cerebrovascular diseases.
- There were clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first administration.
- Arterial and venous thrombosis events occurred within 3 months before the first administration.
- HIV test positive.
- 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.
- Guangdong Provincial People's HospitalGuangzhou, China
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Non-small cell lung carcinoma Primary condition