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A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations

ConditionNon-Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company

About this trial

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years at the time of informed consent form (ICF) signature, either sex.

Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.

Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC).

Presence of at least one measurable target lesion.

Disqualifiers

Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.

Prior or current treatment targeting B7-H3;

Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.;

Prior treatment with docetaxel monotherapy or in combination with other agents.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-20093

    Drug

    Participants will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met.

  • Docetaxel

    Drug

    Participants will receive docetaxel at a dose of 75 mg/m² Q3W until disease progression or other treatment discontinuation criteria are met.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: HS-20093 and adebrelimabExperimental treatment 1 intervention
Group B: DocetaxelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)

Progression-free survival (PFS) assessed by BICR per RECIST v1.1.

Time frame
Approximately 3 years after the fist patient with first dose
2

Overall survival (OS)

Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

Time frame
Approximately 5 years after the fist patient with first dose

Secondary outcomes

1

PFS assessed by investigator

PFS assessed by investigator per RECIST v1.1

Time frame
Approximately 3 years after the fist patient with first dose
2

Objective response rate (ORR)

Objective response rate (ORR) assessed by BICR and investigator per RECIST v1.1

Time frame
Approximately 3 years after the fist patient with first dose
3

Disease control rate (DCR)

Disease control rate (DCR) assessed by BICR and investigator per RECIST v1.1

Time frame
Approximately 3 years after the fist patient with first dose
4

Duration of response (DoR)

Duration of response (DoR) assessed by BICR and investigator per RECIST v1.1

Time frame
Approximately 3 years after the fist patient with first dose

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov

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