Clinical trial NCT06448312: A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official title: A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-07
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
timeFrame: Randomization up to approximately 22months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization up to approximately 40 months
measure: Progression-Free Survival (PFS) assessed by Investigator
timeFrame: Randomization up to approximately 22months
measure: Objective Response Rate (ORR)
timeFrame: Randomization up to approximately 22months
measure: Disease control rate (DCR)
timeFrame: Randomization up to approximately 22months
measure: Duration of Response (DoR)
timeFrame: Randomization up to approximately 22months
measure: Time to Response (TTR)
timeFrame: Randomization up to approximately 22months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Oriental Hospital
Study officials:
References: