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.

Phase
Recruitment status
Not yet recruiting
Participants
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Start date
Number of sites

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
Recruitment status
Not yet recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Registry sponsor category
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design

  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

  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

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No

  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.

  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

  • Guangdong Provincial People's HospitalGuangzhou, China
Sources for sites

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)