A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A2102, Adebrelimab, Paclitaxel, Carboplatin.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug SHR-A2102
SHR-A2102. - Drug Adebrelimab
Adebrelimab. - Drug Paclitaxel
Paclitaxel. - Drug Carboplatin
Carboplatin. - Drug Alomnertinib Mesilate
Alomnertinib Mesilate. - Drug Furmonertini Mesilate
Furmonertini Mesilate. - Drug Osimertinib Mesylate
Osimertinib Mesylate.
Primary outcome measures
- Pathology complete response (pCR) [Time frame: Up to approximately 20 weeks.]
- 18-month event free rate [Time frame: Up to approximately 18 months.]
- 2-years disease free rate [Time frame: Up to approximately 2 years.]
Secondary outcome measures (5)
- Event free survival (EFS) [Time frame: Up to approximately 5 years.]
- Overall survival (OS) [Time frame: Up to approximately 5 years.]
- Objective response rate (ORR) [Time frame: Up to approximately 20 weeks.]
- Disease-Free Survival (DFS) [Time frame: Up to approximately 5 years.]
- Adverse events (AEs) [Time frame: Up to approximately 5 years.]
Eligibility criteria
Inclusion criteria
- Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in writing;
- Participants must be aged between 18 and 70 years old (inclusive) when signing the informed consent form, and both men and women are eligible;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Adequate organ function;
- 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
- With active, known or suspected autoimmune disease of autoimmune disease;
- Malignancies other than NSCLC within 5 years prior to randomization;
- Has or suspected has a history of pneumonitis / interstitial lung disease or any serve lung diseases which will influence the examination of lung function;
- Significant history of cardiovascular and cerebrovascular disease; Significant haemorrhagic disease;
- Has an arteriovenous thrombotic events;
- Has a known history of human immunodeficiency virus (HIV) infection;
- Has a known active Hepatitis B or Hepatitis C;
- Allergic to the intervention regimens.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Identifiers
NCT: NCT07229729 · SHR-A2102-212