A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC

NCT07183189 | Recruiting Phase 3

• 1 other identifier: SHR-A2009-302
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, controlled, open-label, multicenter Phase III clinical trial designed to compare the efficacy and safety of SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment-naïve subjects with EGFR-mutated, locally advanced or metastatic non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by BICR according to RECIST v1.1

  Up to approximately 38 months

Secondary Outcomes (5)

• overall survival (OS)

  Up to approximately 60 months

• Progression Free Survival(PFS by investigator)

  Up to approximately 38months

• Duration of response(DoR，by BICR and investigator )

  Up to approximately 38 months

• Disease control rate（DCR，by BICR and investigator）

  Up to approximately 38 months

• Incidence of AEs

  from Day1 to 40 days after last dose

Study Arms (2)

investigational treatment group：SHR-A2009 combined with Aumolertinib

EXPERIMENTAL

Drug: SHR-A2009 ; Aumolertinib

control group ：Aumolertinib

ACTIVE COMPARATOR

Drug: Aumolertinib

Interventions

SHR-A2009 ; Aumolertinib DRUG

SHR-A2009 administered intravenously, Aumolertinib administered orally.

investigational treatment group：SHR-A2009 combined with Aumolertinib

Aumolertinib DRUG

Aumolertinib administered orally

control group ：Aumolertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
• Subjects with histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations confirmed by tissue or blood specimens.
• No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer.
• At least one measurable tumor lesion according to RECIST v1.1.
• ECOG performance status of 0 or 1.
• Expected survival time ≥12 weeks.
• Adequate bone marrow and organ function.
• Subjects must provide informed consent prior to the trial and voluntarily sign a written informed consent form.

You may not qualify if:

• Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components.
• Subjects with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
• Subjects with uncontrolled tumor-related pain, as determined by the investigator.
• Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
• Insufficient time interval between prior antitumor therapy and the first dose administration.
• Major organ surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
• History of other malignancies within ≤5 years prior to the first dose.
• Subjects with a history of interstitial lung disease, or imaging at screening suggestive of suspected interstitial lung disease; or other moderate to severe pulmonary diseases severely affecting lung function.
• Severe cardiovascular or cerebrovascular diseases.
• Any severe or uncontrolled ocular lesions that, in the physician's judgment, may increase the patient's safety risk.
• Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.
• Severe infections within 4 weeks prior to the first dose.
• Subjects with arterial/venous thromboembolic events within 6 months prior to the first dose of the study drug.
• Active tuberculosis infection.
• History of immunodeficiency, including positive HIV test.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals 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

aumolertinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jun Liu

CONTACT

0518-82342973; jun.liu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 19, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: April 14, 2026

Record last verified: 2025-09

Locations

CN (1)