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NCT Number: NCT07229729

A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Yilong Wu

CONTACT

[email protected]

+86-020-83827812

Yilong Wu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-A2102

Drug

SHR-A2102.

Adebrelimab

Drug

Adebrelimab.

paclitaxel

Drug

Paclitaxel.

carboplatin

Drug

Carboplatin.

Alomnertinib Mesilate

Drug

Alomnertinib Mesilate.

Furmonertini Mesilate

Drug

Furmonertini Mesilate.

Osimertinib Mesylate

Drug

Osimertinib Mesylate.

Primary outcomes

  1. Pathology complete response (pCR)

    Time frame: Up to approximately 20 weeks.

  2. 18-month event free rate

    Time frame: Up to approximately 18 months.

  3. 2-years disease free rate

    Time frame: Up to approximately 2 years.

Secondary outcomes

  1. Event free survival (EFS)

    Time frame: Up to approximately 5 years.

  2. Overall survival (OS)

    Time frame: Up to approximately 5 years.

  3. Objective response rate (ORR)

    Time frame: Up to approximately 20 weeks.

  4. Disease-Free Survival (DFS)

    Time frame: Up to approximately 5 years.

  5. Adverse events (AEs)

    Time frame: Up to approximately 5 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Nov 17, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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