Non-small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DRUGSHR-A2102
SHR-A2102.
DRUGAdebrelimab
Adebrelimab.
DRUGPaclitaxel
Paclitaxel.
DRUGCarboplatin
Carboplatin.
DRUGAlomnertinib Mesilate
Alomnertinib Mesilate.
DRUGFurmonertini Mesilate
Furmonertini Mesilate.
Osimertinib Mesylate.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathology complete response (pCR) | Up to approximately 20 weeks. |
| 18-month event free rate | Up to approximately 18 months. |
| 2-years disease free rate | Up to approximately 2 years. |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival (EFS) | Up to approximately 5 years. |
| Adverse events (AEs) | Up to approximately 5 years. |
| Overall survival (OS) | Up to approximately 5 years. |
| Objective response rate (ORR) | Up to approximately 20 weeks. |
| Disease-Free Survival (DFS) | Up to approximately 5 years. |
Countries
China
Contacts
Primary ContactJunli Wang
Outcome results
None listed