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
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
Treatments tested in this trial
- HC010
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov