A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer

NCT07229729
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
300
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Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
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Start date
2025-11-24
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Number of sites
1
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Summary
The study is a Phase II study to explore the efficacy and safety of SHR-A2102 in combination with other anti-tumor therapies as perioperative treatment in patients with resectable non-small cell lung cancer.
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Short title
A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer
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Official title
A Randomized, Open-label, Multicenter Phase II Clinical Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2029-10-01
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First posted
2025-11-17
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Registry last updated
2025-12-01
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Primary completion date
2026-10-01
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Start date
2025-11-24
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Participants
300
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Participant count basis
Estimated
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Planned participants
300
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Protocol amendments
0
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07229729
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ClinicalTrials.gov ID
NCT07229729
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Pathology complete response (pCR)

    Timeframe: Up to approximately 20 weeks.

  2. 18-month event free rate

    Timeframe: Up to approximately 18 months.

  3. 2-years disease free rate

    Timeframe: Up to approximately 2 years.

  1. Event free survival (EFS)

    Timeframe: Up to approximately 5 years.

  2. Overall survival (OS)

    Timeframe: Up to approximately 5 years.

  3. Objective response rate (ORR)

    Timeframe: Up to approximately 20 weeks.

  4. Disease-Free Survival (DFS)

    Timeframe: Up to approximately 5 years.

  5. Adverse events (AEs)

    Timeframe: Up to approximately 5 years.

Sources for outcomes
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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 procedures and be able to sign the informed consent form in writing;
  2. Participants must be aged between 18 and 70 years old (inclusive) when signing the informed consent form, and both men and women are eligible;
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  4. Adequate organ function;
  5. Women of childbearing age must undergo serum pregnancy tests, and the results must be negative. Female subjects of childbearing age and male subjects who are partners of women of childbearing age must agree to use highly effective contraceptive methods.

  1. With active, known or suspected autoimmune disease of autoimmune disease;
  2. Malignancies other than NSCLC within 5 years prior to randomization;
  3. Has or suspected has a history of pneumonitis / interstitial lung disease or any serve lung diseases which will influence the examination of lung function;
  4. Significant history of cardiovascular and cerebrovascular disease; Significant haemorrhagic disease;
  5. Has an arteriovenous thrombotic events;
  6. Has a known history of human immunodeficiency virus (HIV) infection;
  7. Has a known active Hepatitis B or Hepatitis C;
  8. Allergic to the intervention regimens.
Sources for eligibility
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  • Guangdong Provincial People's HospitalGuangzhou, ChinaRecruiting
Sources for sites
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Related records

Drugs (4)

Lead sponsors (1)

Conditions (1)

Targets (17)