Actively Recruiting
HC010 in First-line PD-L1 Positive Advanced NSCLC Patients
Led by HC Biopharma Inc. · Updated on 2025-12-17
50
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%)
CONDITIONS
Official Title
HC010 in First-line PD-L1 Positive Advanced NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate, communicate well, understand and complete the study process, and sign informed consent.
- Male or female aged 18 years or older at consent.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIb-IV), with PD-L1 expression confirmed by IHC.
- No prior systemic therapy for locally advanced or metastatic NSCLC; if prior adjuvant/neoadjuvant therapy was given, last dose must be at least 6 months before recurrence.
- No EGFR mutation, ROS1 rearrangement, or ALK rearrangement; other target mutations disqualify if corresponding targeted therapies are approved.
- Expected survival of at least 3 months.
- At least one measurable lesion per RECIST v1.1; radiotherapy-treated lesions may not be target lesions unless clearly progressing and the only measurable lesion.
- ECOG performance status 0 or 1, stable within one week before first dose.
- Agree to use effective contraception from consent until 180 days after last study drug dose; negative pregnancy test within 7 days before first dose for females of childbearing potential; females must not be pregnant or lactating during study and up to 6 months after last dose.
You will not qualify if you...
- Use of Chinese patent medicine or immunomodulatory drugs with anti-tumor effects within 2 weeks before first dose.
- Pulmonary radiation therapy exceeding 30 Gy within 6 months before first dose.
- Complete palliative radiotherapy within 7 days before first dose.
- Need for other anti-tumor therapies during the study.
- Pericardial effusion (except stable small amount), uncontrolled or symptomatic pleural or ascites effusions needing drainage.
- Brain stem, meningeal metastases or meningitis carcinoma, spinal cord metastasis or compression.
- Known brain metastases unless clinically stable for at least 4 weeks, no new or growing lesions, and steroid-free for 7 days before first dose.
- Systemic corticosteroids over 10 mg prednisone daily or immunosuppressive drugs within 2 weeks before first dose.
- Serious infection requiring IV antibiotics over 7 days within 2 weeks before first dose or fever over 38.5°C during screening unless tumor-related.
- Other malignancies within 5 years except certain treated cancers.
- Any condition compromising safety or study compliance as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
Q
QiQi Huang, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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