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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: platinum-based dual-agent chemotherapy; Drug: SHR-A2009 monotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06671379

SHR-A2009-301

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

SHR-A2009 monotherapy

Experimental group

Treatment:

Drug: SHR-A2009 monotherapy

platinum-based dual-agent chemotherapy

Active Comparator group

Treatment:

Drug: platinum-based dual-agent chemotherapy