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

NCT07229729 | Recruiting Phase 2

• 1 other identifier: SHR-A2102-212
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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.

Study Arms (2)

SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group

EXPERIMENTAL

Drug: SHR-A2102; Drug: Adebrelimab; Drug: Paclitaxel; Drug: Carboplatin

SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group

ACTIVE COMPARATOR

Drug: SHR-A2102; Drug: Alomnertinib Mesilate; Drug: Furmonertini Mesilate; Drug: Osimertinib Mesylate

Interventions

SHR-A2102 DRUG

SHR-A2102.

SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group; SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group

Adebrelimab DRUG

Adebrelimab.

SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group

Paclitaxel DRUG

Paclitaxel.

SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group

Carboplatin DRUG

Carboplatin.

SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin Group

Alomnertinib Mesilate DRUG

Alomnertinib Mesilate.

SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group

Furmonertini Mesilate DRUG

Furmonertini Mesilate.

SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group

Osimertinib Mesylate DRUG

Osimertinib Mesylate.

SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Carboplatin; osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Junli Wang

CONTACT

+86-0518-82342973; junli.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CN (1)