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

NCT07464327 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HS-20093-309
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

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

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

  Approximately 3 years after the fist patient with first dose

• 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.

  Approximately 5 years after the fist patient with first dose

Secondary Outcomes (6)

• PFS assessed by investigator

  Approximately 3 years after the fist patient with first dose

• Objective response rate (ORR)

  Approximately 3 years after the fist patient with first dose

• Disease control rate (DCR)

  Approximately 3 years after the fist patient with first dose

• Duration of response (DoR)

  Approximately 3 years after the fist patient with first dose

• Incidence and severity of AEs

  From the first dose until 90 days after the last dose

Study Arms (2)

HS-20093 and adebrelimab

EXPERIMENTAL

Drug: HS-20093

Docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

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.

Also known as: Risvutatug Rezetecan, GSK5764227

HS-20093 and adebrelimab

Docetaxel DRUG

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

Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
• Minimum life expectancy \>12 weeks.
• Adequate organ function.
• Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
• Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.

You may not qualify if:

• Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.
• Prior or ongoing treatment with any of the following:
• 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.
• Persistent adverse reactions caused by prior treatment.
• Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms).
• History of other primary malignancies.
• Presence of any of the following abnormal cardiac findings:
• Evidence of currently clinically significant important arrhythmia or ECG abnormality;
• Presence of risk factors causing QT interval prolongation or arrhythmic events.
• Severe, uncontrolled, or active cardiovascular or cerebrovascular disease.
• Severe or poorly controlled hypertension.
• Severe or poorly controlled diabetes mellitus.
• Clinically significant bleeding symptoms or significant bleeding tendency.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03