Health TrialsbyHealthPanel

HC010 in First-line PD-L1 Positive Advanced NSCLC Patients

ConditionNSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHC Biopharma Inc.

About this trial

Phase 2 clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity profile of HC010 for injection in patients with positive PD-L1 (TPS ≥1%)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Voluntarily participate in the study, communicate well with investigators, understand and voluntarily complete the study process according to this protocol, and sign the informed consent form (ICF).

2. Male or female, aged ≥ 18 years at the time of signing the informed consent form.

3. Histologically or cytologically confirmed locally advanced or metastatic (stage IIIb~IV) NSCLC (United States Cancer Confederation [AJCC] 8th edition), positive PD-L1 expression confirmed by IHC with central laboratory or local test results.

4. Not previously receiving systemic therapy for locally advanced or metastatic NSCLC; not allowed if the last dose of prior treatment is <6 months from disease recurrence in subjects who received prior adjuvant or neoadjuvant therapy.

Disqualifiers

1. Subjects who have received Chinese patent medicine or immunomodulatory drugs (including but not limited to thymopeptide, interferon and interleukin) with anti-tumor indications within 2 weeks before the first dose;

2. Pulmonary radiation therapy >30 Gy within 6 months prior to the first dose;

3. Complete palliative radiotherapy within 7 days before the first dose;

4. Any other form of anti-tumor therapy is expected to be required during the study;

Trial design

Design model

Single group

Treatments tested in this trial

  • HC010

    Drug

    HC010 Q3W intravenous infusion

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: HC010Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate (ORR) assessed by the investigator according to RECIST 1.1 criteria;

Time frame
24months

Secondary outcomes

1

Safety and tolerability

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

Time frame
24 months
2

DCR

Disease control rate (DCR), which is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1

Time frame
24 months
3

DoR

Duration of response (DoR), which is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

Time frame
24 months
4

PFS

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.

Time frame
24 months

Other outcomes

Sponsors and contacts

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

HC Biopharma Inc.

Lead sponsor

Source ClinicalTrials.gov
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