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NCT Number: NCT05990127

A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS < 1%.

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Key information

Conditions

Locally Advanced or Metastatic NSCLC 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The first affiliated hospital of bengbu medical college, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
  • Aged ≥18 years when the subject signed the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 3 months.
  • Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer [AJCC] 8th edition).
  • No prior systemic therapy for advanced or metastatic NSCLC was received.
  • PD-L1 TPS < 1%.
  • No EGFR sensitive mutations or ALK gene translocation alterations.

Exclusion criteria

  • Histologically confirmed small cell lung cancer (SCLC).
  • NSCLC with driver gene mutations for approved targeted drug indications.
  • Active central nervous system (CNS) metastases were present.
  • Pulmonary radiation therapy > 30 Gy within 6 months prior to first dose.
  • Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.
  • Pregnant or lactating women.
  • Clinically significant cardiovascular or cerebrovascular disease.
  • Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to all investigational drugs or any of their components.
  • Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.
  • Known active pulmonary tuberculosis.
  • Patients with active hepatitis B or active hepatitis C.
  • Known medical history of immunodeficiency or positive HIV test.

Treatment and study plan

AK104

Drug

AK104 IV, q3w

Tislelizumab

Drug

Tislelizumab IV, q3w

carboplatin

Drug

carboplatin IV, q3w

Pemetrexed

Drug

Pemetrexed IV, q3w (for Nonsquamous NSCLC)

paclitaxel

Drug

Paclitaxel IV, q3w (for squamous NSCLC)

Primary outcomes

  1. Overall Survival(OS)

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

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

  2. Progression-Free Survival(PFS) by investigator(INV)

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1

Secondary outcomes

  1. Progression-Free Survival(PFS) by Blind independent center review(BIRC)

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1

  2. Objective response rate (ORR) was assessed by INV

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    ORR is the proportion of subjects with CR or PR based on RECIST v1.1

  3. Disease control rate (DCR) was assessed by INV

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    Disease control rate (DCR) was assessed based on RECIST V1.1 criteria

  4. Time to response (TTR) was assessed by INV

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    The time from the first administration to the date of documented CR or PR

  5. Duration of response (DOR) was assessed by INV

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria

  6. Objective response rate (ORR) was assessed by BIRC

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    ORR is the proportion of subjects with CR or PR based on RECIST v1.1

  7. Disease control rate (DCR) was assessed BIRC

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    Disease control rate (DCR) was assessed based on RECIST V1.1 criteria

  8. Time to response (TTR) was assessed by BIRC

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    The time from the first administration to the date of documented CR or PR

  9. Duration of response (DOR) was assessed by BIRC

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria

  10. The number of subjects experiencing adverse events (AEs)

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

  11. Pharmacokinetic

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration

  12. Antidrug antibodies (ADA) of AK104

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    Proportion of subjects who develop detectable anti-drug antibodies (ADAs)

  13. Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    EORTC QLQ-C30 measures cancer patients' physical, psychological, and social functions. Scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". Higher score for the functioning scales and global health status denotes a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.

  14. Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 module (EORTC QLQ-LC29)

    Time frame: Through Database Cutoff Date (Up to approximately 39 months)

    EORTC-QLQ-LC29 measures the quality of life in patients with lung cancer. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". For symptoms scales, higher scores indicated greater symptom burden.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhifang Yao, M.D.

CONTACT

[email protected]

+86-0760-89873999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer (NSCLC)

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

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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