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

Not Applicable

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: SHR-A2102; Drug: Adebrelimab; Drug: Alomnertinib Mesilate; Drug: Paclitaxel; Drug: Furmonertini Mesilate; Drug: Carboplatin; Drug: Osimertinib Mesylate

• Registration Number: NCT07229729
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-11-01
• Study First Submitted: 2025-11-13
• Study First Submitted QC: 2025-11-13
• Last Update Submitted: 2025-11-13
• Study First Posted: 2025-11-17
• Last Update Posted: 2025-11-17
• Primary Completion: 2026-10
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group	SHR-A2102	-
SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group	Adebrelimab	-
SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group	Paclitaxel	-
SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group	Carboplatin	-
SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group	SHR-A2102	-
SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group	Alomnertinib Mesilate	-
SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group	Furmonertini Mesilate	-
SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group	Osimertinib Mesylate	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Event free survival (EFS)	Up to approximately 5 years.
Overall survival (OS)	Up to approximately 5 years.
Disease-Free Survival (DFS)	Up to approximately 5 years.
Objective response rate (ORR)	Up to approximately 20 weeks.
Adverse events (AEs)	Up to approximately 5 years.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China