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

ConditionLocally Advanced or Metastatic NSCLC
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkeso

About this trial

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%.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

642 Participants
are divided into 2 treatment groups
Group A: AK104 armExperimental treatment 4 interventions
Group B: Tislelizumab armActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Overall Survival(OS)

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

Time frame
Through Database Cutoff Date (Up to approximately 39 months)
2

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

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

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

Secondary outcomes

1

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

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

Time frame
Through Database Cutoff Date (Up to approximately 39 months)
2

Objective response rate (ORR) was assessed by INV

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

Time frame
Through Database Cutoff Date (Up to approximately 39 months)
3

Disease control rate (DCR) was assessed by INV

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

Time frame
Through Database Cutoff Date (Up to approximately 39 months)
4

Time to response (TTR) was assessed by INV

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: