Evaluating SKB264 with Pembrolizumab for Lung Cancer Treatment

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

This study is testing if a new drug called SKB264, when used with pembrolizumab, works better than standard chemotherapy with pembrolizumab for patients with advanced lung cancer that has a specific marker.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 432 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. (Industry-sponsored)
• Drugs / interventions: pembrolizumab, chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06711900 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial investigates the efficacy and safety of SKB264 combined with pembrolizumab compared to chemotherapy combined with pembrolizumab as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that is PD-L1 negative. The study is randomized and open-label, involving multiple centers to ensure diverse patient representation. Participants will be monitored for treatment outcomes and safety profiles to determine the effectiveness of SKB264 in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with locally advanced or metastatic non-squamous NSCLC who are PD-L1 negative and have not received prior systemic therapy.

Not a fit: Patients with specific genetic mutations that are eligible for targeted therapies or those with other types of lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with PD-L1 negative non-squamous NSCLC.

How similar studies have performed: Other studies have shown promising results with immunotherapy combinations in lung cancer, but this specific combination is being evaluated for the first time.

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;

Where this trial is running

Shanghai

• Shanghai Oriental Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xiaoping Jin, PhD

Conditions Non-Small Cell Lung Cancer