Comparing SHR-A2009 to Platinum-based Chemotherapy for Advanced Lung Cancer

A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy

This study is testing a new treatment called SHR-A2009 to see if it works better than standard chemotherapy for people with advanced lung cancer who haven't responded to other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06671379 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial aims to evaluate the efficacy and safety of SHR-A2009 compared to standard platinum-based dual-agent chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have previously failed EGFR TKI treatment. The study is randomized, controlled, and open-label, involving multiple centers. Participants will be monitored for measurable tumor response and overall survival outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable advanced or metastatic non-squamous NSCLC who have previously been treated with EGFR-TKI.

Not a fit: Patients with active central nervous system metastases or those who have recently undergone significant antitumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with EGFR-mutated advanced NSCLC who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promising results with similar targeted therapies in EGFR-mutated lung cancer, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 75 years old (inclusive), Female or male
2. Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
3. Previously treated by EGFR-TKI；
4. At least one measurable tumor lesion according to RECIST v1.1
5. ECOG performance score of 0-1;
6. Expected survival time ≥ 12 weeks;
7. Adequate bone marrow and organ function
8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Subjects with active central nervous system (CNS) metastases.
2. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
3. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
4. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
5. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
6. 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
7. Serious cardiovascular disease
8. Presence of severe infection within 4 weeks prior to first dose of study drug
9. Arterial/venous thrombotic events within 3 months prior to the first study dose
10. History of immunodeficiency, including a positive HIV test
11. Presence of active hepatitis B or C;
12. History of allergic reactions to any component of study treatment or severe allergic reactions to other monoclonal antibodies.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Fei Qiu

Conditions Non-small Cell Lung Cancer