A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC

NCT06671379 | Active Not Recruiting Phase 3

• 1 other identifier: SHR-A2009-301
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.

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 32 months

Secondary Outcomes (5)

• overall survival (OS)

  Up to approximately 32 months

• Progression Free Survival(PFS by investigator)

  Up to approximately 32 months

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

  Up to approximately 32 months

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

  Up to approximately 32 months

• Incidence of AEs

  from Day1 to 40 days after last dose

Study Arms (2)

SHR-A2009 monotherapy

EXPERIMENTAL

Drug: SHR-A2009 monotherapy

platinum-based dual-agent chemotherapy

ACTIVE COMPARATOR

Drug: platinum-based dual-agent chemotherapy

Interventions

SHR-A2009 monotherapy DRUG

SHR-A2009 monotherapy ，SHR-A2009 will be administered intravenously

SHR-A2009 monotherapy

platinum-based dual-agent chemotherapy DRUG

Pemetrexed combined with carboplatin or cisplatin, after four cycles of combination, pemetrexed was continued as a single agent，all drugs will be administered intravenously

platinum-based dual-agent chemotherapy

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 old (inclusive), Female or male
• Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
• Previously treated by EGFR-TKI；
• At least one measurable tumor lesion according to RECIST v1.1
• ECOG performance score of 0-1;
• Expected survival time ≥ 12 weeks;
• Adequate bone marrow and organ function
• Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

You may not qualify if:

• Subjects with active central nervous system (CNS) metastases.
• Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
• Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
• Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
• Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
• Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
• Serious cardiovascular disease
• Presence of severe infection within 4 weeks prior to first dose of study drug
• Arterial/venous thrombotic events within 3 months prior to the first study dose
• History of immunodeficiency, including a positive HIV test
• Presence of active hepatitis B or C;
• History of allergic reactions to any component of study treatment or severe allergic reactions to other monoclonal antibodies.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

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: November 1, 2024
• First Posted: November 4, 2024
• Study Start: November 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)