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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: SHR-A2102; Drug: Adebrelimab; Drug: Paclitaxel; Drug: Alomnertinib Mesilate; Drug: Furmonertini Mesilate; Drug: Osimertinib Mesylate

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Junli Wang; Phone Number: +86-0518-82342973; Email: junli.wang@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Principal Investigator: Yilong Wu
      • Contact: Yilong Wu; Phone Number: +86-020-83827812; Email: syylwu@live.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group	Drug: Carboplatin; Carboplatin.; Drug: SHR-A2102; SHR-A2102.; Drug: Adebrelimab; Adebrelimab.; Drug: Paclitaxel; Paclitaxel.
Active Comparator: SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group	Drug: SHR-A2102; SHR-A2102.; Drug: Alomnertinib Mesilate; Alomnertinib Mesilate.; Drug: Furmonertini Mesilate; Furmonertini Mesilate.; Drug: Osimertinib Mesylate; Osimertinib Mesylate.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Event free survival (EFS)	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.
Adverse events (AEs)	Up to approximately 5 years.

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Carboplatin; Paclitaxel; osimertinib
• Other Study ID Numbers: SHR-A2102-212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No