NSCLCPhase 2NCT07169552
HC010 in First-line PD-L1 Positive Advanced NSCLC Patients
A Phase 2 study testing HC010 in people with NSCLC, run by HC Biopharma Inc. at 1 site in China.
Trial summary
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%) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- HC010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2025to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 5. No EGFR mutation/ROS1 rearrangement/ALK rearrangement. If other targeted mutations such as BRAF V600E mutation/NTRK1/2/3 gene fusion/MET14 exon skipping mutation/RET rearrangement positive are known, they will not be included in this study if the corresponding targeted therapy drugs have been approved.
- 6. Expected survival ≥ 3 months.
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- 7.There should be at least one measurable lesion according to RECIST v1.1; radiotherapy-experienced lesions may not be selected as target lesions, unless the radiotherapy lesion is the only measurable lesion and clearly progresses based on imaging judgment.
- 8. Eastern Cooperative Oncology Group (ECOG) performance status scored 0 or 1 in the United States and did not worsen within one week prior to first dose.
- 9. Subjects (both female and male) agreed to use effective contraception from signing the ICF until 180 days after last dose of investigational product. Female patients of childbearing potential must have a negative blood or urine pregnancy test within 7 days prior to the first dose; females who are not pregnant or lactating from signing informed consent until 6 months after the last use of investigational drug (including those who agree to stop breastfeeding during this period).
Who cannot join
- 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;
- 5. Pericardial effusion (a stable small amount of pericardium can be included actively), or uncontrolled or symptomatic pleural and ascites effusions requiring puncture drainage;
- 6. Presence of brain stem, meningeal metastases/meningitis carcinoma, spinal cord metastasis or compression;
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- 7. Known brain metastases. Previously treated subjects with brain metastasis may participate in the study if they are clinically stable for at least 4 weeks prior to first dose, have no evidence of new or expanded brain metastases, and discontinue steroids 7 days prior to first dose. According to this definition, the stability of brain metastasis should be established prior to the first dose of study drug. Subjects with known untreated asymptomatic brain metastases stable for at least 4 weeks (i.e., no neurological symptoms, no corticosteroid treatment required, no or only slight peripheral edema, no lesion >1.5 cm, or stable brain lesion as determined by imaging) can participate in the study;
- 8. Patients who have taken systemic corticosteroids (> 10 mg prednisone or equivalent daily) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) within 2 weeks prior to the first dose;
- 9. Systemic infection or other serious infection requiring intravenous antibiotics for >7 days within 2 weeks prior to the first dose, or fever of unexplained origin >38.5 °C during screening and before enrollment (except for fever due to tumor in the investigator's judgment).
- 10. Concurrent with other malignant tumors within 5 years before the first dose, except for patients with adequately treated cervical carcinoma in situ, basal cell, squamous epithelial cell skin cancer, papillary thyroid carcinoma, local prostate cancer after radical resection and ductal carcinoma in situ after radical resection;
- 11. Subjects with diseases that may jeopardize their safety or compliance with the study protocol, and other conditions unsuitable for participation in this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Caicun Zhou, PHD, 13301825532, caicunzhoudr@163.com
About this study
Official title: A Multicenter, Single-arm, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of HC010 for Injection in the First-line Treatment of Advanced Non-small Cell Lung Cancer Positive for Programmed Death Ligand-1 (PD-L1)
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%)
Read the detailed description
This is a multicenter, single-arm, open-label Phase 2 clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity profile of HC010 for injection as monotherapy in first-line treatment of locally advanced or metastatic non-small cell lung cancer with positive PD-L1 (TPS ≥1%), negative EGFR mutations and negative ALK.
- Conditions
- NSCLC
- Being tested
- HC010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC010Drug
HC010 Q3W intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| HC010 | Experimental | Not described Receives: Drug: HC010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (ORR) assessed by the investigator according to RECIST 1.1 criteria;
Measured: 24months
Secondary outcomes (5)
Safety and tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
Measured: 24 months
DCR
Disease control rate (DCR), which is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
OS
Overall Survival (OS) in the ITT population
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start9 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HC Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169552
- Sponsor's protocol ID
- BT-HC010-201
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of HC010 for Injection in the First-line Treatment of Advanced Non-small Cell Lung Cancer Positive for Programmed Death Ligand-1 (PD-L1)
- ClinicalTrials.gov ID
- NCT07169552
- Acronym / sponsor ID
- BT-HC010-201
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HC Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%)
Detailed description
This is a multicenter, single-arm, open-label Phase 2 clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity profile of HC010 for injection as monotherapy in first-line treatment of locally advanced or metastatic non-small cell lung cancer with positive PD-L1 (TPS ≥1%), negative EGFR mutations and negative ALK.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HC010 | Experimental | Drug: HC010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 5. No EGFR mutation/ROS1 rearrangement/ALK rearrangement. If other targeted mutations such as BRAF V600E mutation/NTRK1/2/3 gene fusion/MET14 exon skipping mutation/RET rearrangement positive are known, they will not be included in this study if the corresponding targeted therapy drugs have been approved.
Key exclusion criteria (11 listed)
- 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;
- 5. Pericardial effusion (a stable small amount of pericardium can be included actively), or uncontrolled or symptomatic pleural and ascites effusions requiring puncture drainage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC010HC010 Q3W intravenous infusion | Drug | HC010 |
Primary outcome
ORR
Time frame: 24months
Objective response rate (ORR) assessed by the investigator according to RECIST 1.1 criteria;
5 secondary outcomes
Safety and tolerability
Time frame: 24 months
DCR
Time frame: 24 months
DoR
Time frame: 24 months
PFS
Time frame: 24 months
OS
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HC010 in people with NSCLC, run by HC Biopharma Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QiQi Huang, master (18221247718, qiqi.huang@btyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.