Clinical trial · Interventional
A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| platinum-based dual-agent chemotherapy | Drug | — | UNRESOLVED |
| SHR-A2009 monotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-A2009 monotherapy
- interventionNames
- Drug: SHR-A2009 monotherapy
- type
- ACTIVE_COMPARATOR
- label
- platinum-based dual-agent chemotherapy
- interventionNames
- Drug: platinum-based dual-agent chemotherapy
Primary outcomes (1)
- measure
- Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
- timeFrame
- Up to approximately 32 months
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available