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

NCT ID: NCT06711900

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2028-12-31

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SKB264+Pembrolizumab

Participants will receive SKB264 on Day 1、Day 15 and Day 29 of each 6-week cycle,Pembrolizumab on Day1 of each 6-week cycle.

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

IV Infusion

Pembrolizumab

Intervention Type: DRUG

IV Infusion

Pembrolizumab+Chemotherapy

Participants will receive Pembrolizumab on Day1 of each 6-week cycle,Chemotherapy on Day1 and Day 22 of each 6-week

Group Type: ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type: DRUG

IV Infusion

pemetrexed

Intervention Type: DRUG

IV Infusion

carboplatin or cisplatin

Intervention Type: DRUG

IV Infusion

Interventions

SKB264

IV Infusion

Intervention Type: DRUG

Pembrolizumab

IV Infusion

Intervention Type: DRUG

pemetrexed

IV Infusion

Intervention Type: DRUG

carboplatin or cisplatin

IV Infusion

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Oriental Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoping Jin, PhD

Role: CONTACT

jinxp@kelun.com

86-028-67255165

Facility Contacts

Caicun Zhou

Role: primary

caicunzhoudr@163.com

13301825532

Other Identifiers

SKB264-Ⅲ-14

Identifier Type: -

Identifier Source: org_study_id