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A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Henlius Biotech

About this trial

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;

Aged ≥ 18 years at the time of signing the ICF, male or female;

Subjects with non-squamous NSCLC must have documented negative test results for EGFR and ALK alterations. If no prior test results for EGFR and ALK are available, subjects must undergo EGFR and ALK testing at the study site. For subjects with squamous NSCLC, EGFR and/or ALK testing is not required prior to enrollment if their status is unknown;

No other known actionable genomic alterations, such as ROS1, NTRK, BRAF, MET exon 14 skipping, and RET;

Disqualifiers

Histologically or cytologically confirmed tumor containing components of small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;

Prior treatment with any medication targeting topoisomerase I, including chemotherapy or ADCs;

Radical radiation therapy within 3 months prior to the first dose;

History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX43 DOSE 1 (2.0 mg/kg)

    Drug

    Dose 1; 2.0 mg/kg; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 DOSE 2 (2.5 mg/kg)

    Drug

    Dose 2; 2.5 mg/kg; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

Treatment groups

243 Participants
are divided into 2 treatment groups
Group A: HLX43 DOSE 1 (2.0 mg/kg)Experimental treatment 1 intervention
Group B: HLX43 DOSE 2 (2.5 mg/kg)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate (ORR) (assessed by the Independent Radiology Review Committee \[IRRC\] as per RECIST v1.1).

Time frame
From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months

Secondary outcomes

1

ORR

Objective response rate (ORR) (assessed by the investigator as per RECIST v1.1).

Time frame
From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
2

PFS

Progression-free survival (PFS) (assessed by the IRRC and the investigator as per RECIST v1.1)

Time frame
From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
3

OS

Overall survival (OS)

Time frame
From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
4

Incidence and severity of adverse events (AEs)

severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version \[v\] 5.0, vital signs and clinical laboratory test results

Time frame
From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months

Other outcomes

Sponsors and contacts

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

Shanghai Henlius Biotech

Lead sponsor

Henlius USA Inc.

Collaborator

Source ClinicalTrials.gov
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