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

NCT07824882 | Not Yet Recruiting Phase 2

• 1 other identifier: HS-20093-209
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, open-label, controlled phase II clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus HS-20093 injection 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

Keywords

Non-Small Cell Lung Cancer; HS-20093; B7H3; Antibody-Drug Conjugates; PD-L1 inhibitor

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) assessed by investigator per RECIST v1.1

  Up to 3 years

• Progression-Free Survival (PFS)

  2\. Progression-Free Survival (PFS) assessed by investigator per RECIST v1.1

  Approximately 3 years

Secondary Outcomes (4)

• duration of response (DoR)

  Approximately 3 years

• Overall survival (OS)

  Approximately 5 years

• Adverse event (AE) and serious adverse event (SAE)

  3 years

• Changes from baseline in cardiac function [electrocardiogram (ECG)]

  3 years

Study Arms (2)

HS-20093 and adebrelimab

EXPERIMENTAL

Drug: HS-20093 for Injection; Drug: Adebrelimab Injection

HS-20093

ACTIVE COMPARATOR

Drug: HS-20093 for Injection

Interventions

HS-20093 for Injection DRUG

The patient will be treated with HS-20093.

Also known as: Risvutatug Rezetecan, Ris-Rez, GSK5764227

HS-20093; HS-20093 and adebrelimab

Adebrelimab Injection DRUG

The patient will be treated with Adebrelimab

HS-20093 and adebrelimab

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

Injections

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)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: September 17, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09