Clinical trial NCT06711900: A Study of SKB264 in Combination with Pembrolizumab Versus Chemotherapy in Combination with Pembrolizumab As First-Line Treatment for PD-L1 Negative Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Official title: A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination with Pembrolizumab Versus Chemotherapy in Combination with Pembrolizumab As First-Line Treatment for PD-L1 Negative Patients with Locally Advanced or Metastatic Non-Squamous 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: 2024-12-02
Enrollment: 432
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 study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.

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 chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed non-squamous NSCLC, and unsuitable for radical surgery and/or radical concurrent/sequential radiochemotherapy, locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC;
2. EGFR-sensitive mutation negative \[no exon 19 deletion (19-Del) or exon 21 point mutation (L858R mutation)\] and ALK fusion gene negative, without known ROS1 gene fusion, NTRK gene fusion, BRAF V600E mutation, etc. that have been approved for targeted therapy driving gene alterations;
3. No prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC;
4. Participants whose tumours are PD-L1 TPS ≥ 1%;
5. At least one measurable lesion per RECIST v1.1;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization;
7. A life expectancy of at least 12 weeks;
8. Adequate organ and bone marrow function;

Exclusion Criteria:

1. Histologically or cytologically confirmed tumors with a component of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell carcinoma exceeding 10%;
2. Previously received immune checkpoint inhibitors,checkpoint agonists or any treatment targeting the immune mechanism of tumors such as immune cell therapy;
3. Active second malignancy;
4. Symptomatic or uncontrolled cardiovascular disease，serious thromboembolic；
5. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
6. Active infection requiring systemic therapy within 2 weeks of randomization;
7. Active hepatitis B or hepatitis C virus infection;
8. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
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 28 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization up to approximately 43 months
measure: Progression-Free Survival (PFS) assessed by Investigator
timeFrame: Randomization up to approximately 28 months
measure: Objective Response Rate (ORR)
timeFrame: Randomization up to approximately 28 months
measure: Disease control rate (DCR)
timeFrame: Randomization up to approximately 28 months
measure: Duration of Response (DoR)
timeFrame: Randomization up to approximately 28 months
measure: Time to Response (TTR)
timeFrame: Randomization up to approximately 28 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Oriental Hospital
Study officials:
References: