Non-small Cell Lung Cancer
Conditions
Brief summary
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.
Detailed description
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy. The primary objective is to compare the efficacy and safety of SKB264 monotherapy versus pemetrexed in combination with platinum in patients with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.
Interventions
DRUGSKB264
intravenous (IV) infusion (Q2W)
DRUGPemetrexed
500 mg/m2 intravenous (IV) infusion (Q3W)
DRUGCarboplatin
AUC 5 intravenous (IV) infusion (Q3W) 4cycles
DRUGCisplatin
75 mg/m2 intravenous (IV) infusion (Q3W) 4cycles
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical 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. Males or females aged ≥18 to ≤75 years at the time of signing the ICF; 2. Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy; 3. EGFR-sensitive mutations; 4. Failure of prior EGFR-TKI therapy; 5. At least one measurable target lesion per RECIST 1.1 as assessed by the investigator; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. Expected survival ≥12 weeks; 8. Adequate organ and bone marrow function; 9. Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose; 10. Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures
Exclusion criteria
1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%; 2. Other malignancies within 3 years prior to the first dose; 3. History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis; 4. Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed; 5. Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria; 6. Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; 7. Prior TROP2-targeted therapy; 8. Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs); 9. Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study; 10. Subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study; 11. Pregnant or lactating women;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months | PFS assessed by BIRC per RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | From the date of randomization to the date of death due to any cause. Up to 2 years. | Overall survival (OS) |
| Progression-free survival (PFS) | From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months | PFS assessed by the investigator per RECIST 1.1 |
| Objective response rate(ORR) | Up to 2 years | ORR assessed by the investigator and BIRC per RECIST 1.1 |
| Disease control rate(DCR) | Up to 2 years | DCR assessed by the investigator and BIRC per RECIST 1.1 |
| Duration of response(DOR) | From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months | DOR assessed by the investigator and BIRC per RECIST 1.1 |
| Time to response(TTR) | Up to 2 years | TTR assessed by the investigator and BIRC per RECIST 1.1 |
| AEs and SAEs | AEs should be observed and recorded from signing the ICF until 30 days after the last dose. AEs occurring 30 days after the last dose are not required to be actively collected by the investigator. | Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings |
| Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30） | Up to 2 years | To assess the impact of SKB264 on disease related symptoms and health related quality of life (HRQoL) in this patient population. |
| Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) complementary 13-item quality-of-life questionnaire - lung cancer symptoms questionnaire (QLQ-LC13) | Up to 2 years | To assess the impact of SKB264 on disease related symptoms and health related quality of life (HRQoL) in this patient population |
Countries
China
Outcome results
None listed