A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 3

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: SKB264; Drug: Pembrolizumab

• Registration Number: NCT06448312
• Lead Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

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.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 406

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SKB264+Pembrolizumab	SKB264	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.
SKB264+Pembrolizumab	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.
Pembrolizumab	Pembrolizumab	Participants will receive Pembrolizumab on Day 1 of each 6-week cycle.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)	Randomization up to approximately 22months	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.

Secondary Outcome Measures

Name	Time	Method
Time to Response (TTR)	Randomization up to approximately 22months	TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1.
Progression-Free Survival (PFS) assessed by Investigator	Randomization up to approximately 22months	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.
Duration of Response (DoR)	Randomization up to approximately 22months	DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first.
Objective Response Rate (ORR)	Randomization up to approximately 22months	ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1
Disease control rate (DCR)	Randomization up to approximately 22months	DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/ investigator per RECIST 1.1
Overall Survival (OS)	Randomization up to approximately 40 months	OS is defined as the time from randomization until the date of death due to any cause.

Trial Locations

Locations (1)

Shanghai Oriental Hospital; 🇨🇳 Shanghai, China