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NCT Number: NCT06711900

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

SKB264

Drug

IV Infusion

Pembrolizumab

Drug

IV Infusion

Pemetrexed

Drug

IV Infusion

Carboplatin or Cisplatin

Drug

IV Infusion

Primary outcomes

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

    Time frame: Randomization up to approximately 28 months

    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 outcomes

  1. Overall Survival (OS)

    Time frame: Randomization up to approximately 43 months

    OS is defined as the time from randomization until the date of death due to any cause.

  2. Progression-Free Survival (PFS) assessed by Investigator

    Time frame: Randomization up to approximately 28 months

    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.

  3. Objective Response Rate (ORR)

    Time frame: Randomization up to approximately 28 months

    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

  4. Disease control rate (DCR)

    Time frame: Randomization up to approximately 28 months

    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

  5. Duration of Response (DoR)

    Time frame: Randomization up to approximately 28 months

    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.

  6. Time to Response (TTR)

    Time frame: Randomization up to approximately 28 months

    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.

  7. AEs and SAEs

    Time frame: All AEs should be observed and recorded from the first dose until 30 days after the last dose. SAEs were observed and recorded until 90 days after the last dose of pembrolizumab or 30 days after the last dose of SKB264,whichever occurred later.

    Incidence and severity of AEs and SAEs (per CTCAE v5.0), and clinically significant abnormal laboratory results

  8. Health-Related Quality of Life Assessed by EORTC QLQ-C30

    Time frame: Randomization up to approximately 28months

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is used to assess participants's health-related quality of life. The scale covers functional domains, symptom domains, and overall health status/total quality of life domain.

    All domain scores are standardized to a range of 0 to 100. For functional domains and overall health status/total quality of life, higher scores indicate better functional status and quality of life; for symptom domains, higher scores indicate more symptoms or problems (worse quality of life).

    This study will compare changes from baseline in quality-of-life scores across all dimensions, analyze time to deterioration in general health status, symptoms and function, and summarize the number and percentage of participants with clinically meaningful changes post-baseline.

  9. Lung Cancer-Related Symptoms Assessed by EORTC QLQ-LC13 Symptom Domain

    Time frame: From randomization up to approximately 28 months

    The symptom domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) is used to assess lung cancer-related symptoms and treatment-related symptoms. The scale includes both multiple-item and single-item measurement parameters.

    Scores are standardized to a range of 0 to 100. Higher scores indicate more severe symptoms (worse outcome).

    This study will compare changes from baseline in symptom scores, analyze time to deterioration of cancer-related symptoms, and summarize the number and percentage of participants with clinically meaningful changes post-baseline.

  10. PK

    Time frame: Randomization up to approximately 28months

    PK parameters of SKB264-ADC, SKB264-TAB and free KL610023, such as maximum concentration (Cmax), minimum concentration (Cmin ), etc.

  11. Immunogenicity

    Time frame: Randomization up to approximately 28months

    Anti-drug antibody (ADA) of SKB264 in the serum of subjects will be determined using MSD-based Bridging-ECLA.

  12. Biomarkers

    Time frame: Tumor tissue samples should be provided for TROP2 testing after subjects are eligible for screening.

    Correlation between the expression level of TROP2 in tumor tissues and the efficacy.

Sponsors and collaborators

Lead sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-Label, Multicenter Phase 3 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 2, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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