Non-small Cell Lung Cancer
Conditions
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.
Interventions
DRUGSHR-A2009 monotherapy
SHR-A2009 monotherapy ，SHR-A2009 will be administered intravenously
DRUGplatinum-based dual-agent chemotherapy
Pemetrexed combined with carboplatin or cisplatin, after four cycles of combination, pemetrexed was continued as a single agent，all drugs will be administered intravenously
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) assessed by BICR according to RECIST v1.1 | Up to approximately 32 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed