To hear about similar clinical trials, please enter your email below
Trial Title:
A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients
NCT ID:
NCT05870319
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SKB264
Description:
intravenous (IV) infusion (Q2W)
Arm group label:
SKB264 by IV infusion on Days 1 and 15 of each 4-week cycle;
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
500 mg/m2 intravenous (IV) infusion (Q3W)
Arm group label:
pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC 5 intravenous (IV) infusion (Q3W) 4cycles
Arm group label:
pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
75 mg/m2 intravenous (IV) infusion (Q3W) 4cycles
Arm group label:
pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo
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.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhang, PHD
Phone:
020-87343458
Email:
zhangli@sysucc.org.cn
Start date:
June 26, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870319
