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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448312
• Other study ID #: SKB264-?-12
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: November 2026

Study information

• Verified date: June 2024
• Source: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
• Contact: Xiaoping Jin, PhD
• Phone: 86-028-67255165
• Email: jinxp[@]kelun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 406
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:Key Inclusion Criteria:

1. Histologically or cytologically confirmed NSCLC that is locally advanced (Stage ?B/?C) 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• SKB264
IV Infusion
• Pembrolizumab
IV Infusion

Locations

Country	Name	City	State
China	Shanghai Oriental Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 22months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization until the date of death due to any cause.	Randomization up to approximately 40 months
Secondary	Progression-Free Survival (PFS) assessed by Investigator	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.	Randomization up to approximately 22months
Secondary	Objective Response Rate (ORR)	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	Randomization up to approximately 22months
Secondary	Disease control rate (DCR)	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	Randomization up to approximately 22months
Secondary	Duration of Response (DoR)	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.	Randomization up to approximately 22months
Secondary	Time to Response (TTR)	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.	Randomization up to approximately 22months