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

NCT06711900 | Recruiting Phase 3 DMC

• 1 other identifier: SKB264-Ⅲ-14
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

  PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.

  Randomization up to approximately 28 months

Secondary Outcomes (6)

• Overall Survival (OS)

  Randomization up to approximately 43 months

• Progression-Free Survival (PFS) assessed by Investigator

  Randomization up to approximately 28 months

• Objective Response Rate (ORR)

  Randomization up to approximately 28 months

• Disease control rate (DCR)

  Randomization up to approximately 28 months

• Duration of Response (DoR)

  Randomization up to approximately 28 months

Study Arms (2)

SKB264+Pembrolizumab

EXPERIMENTAL

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.

Drug: SKB264; Drug: Pembrolizumab

Pembrolizumab+Chemotherapy

ACTIVE COMPARATOR

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

Drug: Pembrolizumab; Drug: pemetrexed; Drug: carboplatin or cisplatin

Interventions

SKB264 DRUG

IV Infusion

SKB264+Pembrolizumab

Pembrolizumab DRUG

IV Infusion

Pembrolizumab+Chemotherapy; SKB264+Pembrolizumab

pemetrexed DRUG

IV Infusion

Pembrolizumab+Chemotherapy

carboplatin or cisplatin DRUG

IV Infusion

Pembrolizumab+Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• No prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC;
• Participants whose tumours are PD-L1 TPS \< 1%;
• At least one measurable lesion per RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization;
• A life expectancy of at least 12 weeks;
• Adequate organ and bone marrow function;

You may not qualify if:

• Histologically or cytologically confirmed tumors with a component of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell carcinoma exceeding 10%;
• Previously received immune checkpoint inhibitors,checkpoint agonists or any treatment targeting the immune mechanism of tumors such as immune cell therapy;
• Active second malignancy;
• Symptomatic or uncontrolled cardiovascular disease，serious thromboembolic；
• History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
• Active infection requiring systemic therapy within 2 weeks of randomization;
• Active hepatitis B or hepatitis C virus infection;
• Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
• Major surgery within 4 weeks prior to randomization or expected major surgery during the study;
• Pregnant or lactating women;

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Oriental Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Pemetrexed; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Xiaoping Jin, PhD

CONTACT

86-028-67255165; jinxp@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomised in a 1:1 ratio to one of two intervention groups.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 2, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CN (1)