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Trial Title:
A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID:
NCT06448312
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SKB264
Description:
IV Infusion
Arm group label:
SKB264+Pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
IV Infusion
Arm group label:
Pembrolizumab
Arm group label:
SKB264+Pembrolizumab
Summary:
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with
pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or
metastatic non-small cell lung cancer (NSCLC).
Detailed description:
This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and
safety of SKB264 in combination with pembrolizumab versus pembrolizumab as firstline
treatment for PD-L1 positive patients with locally advanced or metastatic non-small cell
lung cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:Key Inclusion Criteria:
1. Histologically or cytologically confirmed NSCLC that is locally advanced (Stage
ⅢB/ⅢC) or metastatic (Stage IV) NSCLC that is not amenable to radical surgery and/or
radical radiotherapy regardless of concurrent chemotherapy.
2. No prior systemic anti-cancer therapy for locally advanced or metastatic disease.
3. Participants whose tumours are PD-L1 TPS ≥ 1%.
4. At least one measurable lesion per RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no
worsening within 7 days prior to randomization.
6. A life expectancy of at least 12 weeks.
7. Adequate organ and bone marrow function.
Exclusion Criteria:Key Exclusion Criteria:
1. Active second malignancy.
2. Uncontrolled or clinical significant cardiovascular disease.
3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required
steroids or has current pneumonitis/ILD.
4. Active infection requiring systemic therapy within 2 weeks of randomization.
5. Active hepatitis B or hepatitis C virus infection.
6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency
syndrome (AIDS); known active syphilis infection.
7. Known allergy to SKB264 or pembrolizumab or any of its components.
8. Prior treatment with any of the following (including in the context of adjuvant,
neoadjuvant therapy):
1. Immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibody, anti-CTLA-4
antibody, etc.), checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40
antibody, etc.), any treatment targeting the immune mechanism of tumors such as
immune cell therapy;
2. Therapy targeting TROP2.
3. Any drug therapy that targets topoisomerase I, including antibody-drug
conjugates (ADCs).
9. Major surgery within 4 weeks prior to randomization or expected major surgery during
the study.
10. Pregnant or lactating women.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Oriental Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou
Phone:
13301825532
Email:
caicunzhoudr@163.com
Start date:
June 2024
Completion date:
November 2026
Lead sponsor:
Agency:
Sichuan Kelun Pharmaceutical Research Institute 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/NCT06448312
