Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:10 AM
Study NCT ID:
NCT07360132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer
Sponsor:
Shanghai Huaota Biopharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Multicenter Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized, controlled, double-blind, multi-center phase III registration clinical trial, aiming to observe, compare and evaluate the efficacy and safety of HB0025 combined with paclitaxel + carboplatin compared with pembrolizumab combined with paclitaxel + carboplatin as the first-line treatment for locally advanced or metastatic squamous NSCLC.
The study subjects are patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who have not received systemic anti-tumor treatment before. The study will use the PFS evaluated by BICR as the primary endpoint, and plan to enroll approximately 480 subjects, with the proportion of locally advanced subjects not exceeding 10%.
The subjects were fully informed and signed the informed consent form. If they met the inclusion criteria but did not meet the exclusion criteria, they were randomly assigned in a 1:1 ratio to receive HB0025 combined with chemotherapy Paclitaxel plus Platinum (experimental group) or pembrolizumab combined with chemotherapy Paclitaxel plus Platinum (control group). Both were administered once every 3 weeks (Q3W). After 4 cycles of treatment, Enter HB0025 or pembrolizumab monotherapy maintenance treatment (Q3W) until the investigator determines that there is no longer any clinical benefit (based on the RECIST v1.1 imaging assessment and comprehensive clinical symptom assessment by the investigator), intolerable toxicity occurs, 24 months of study treatment is completed, or other treatment termination criteria in the protocol are met. Whichever occurs first shall prevail.
The study subjects are patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who have not received systemic anti-tumor treatment before. The study will use the PFS evaluated by BICR as the primary endpoint, and plan to enroll approximately 480 subjects, with the proportion of locally advanced subjects not exceeding 10%.
The subjects were fully informed and signed the informed consent form. If they met the inclusion criteria but did not meet the exclusion criteria, they were randomly assigned in a 1:1 ratio to receive HB0025 combined with chemotherapy Paclitaxel plus Platinum (experimental group) or pembrolizumab combined with chemotherapy Paclitaxel plus Platinum (control group). Both were administered once every 3 weeks (Q3W). After 4 cycles of treatment, Enter HB0025 or pembrolizumab monotherapy maintenance treatment (Q3W) until the investigator determines that there is no longer any clinical benefit (based on the RECIST v1.1 imaging assessment and comprehensive clinical symptom assessment by the investigator), intolerable toxicity occurs, 24 months of study treatment is completed, or other treatment termination criteria in the protocol are met. Whichever occurs first shall prevail.
Detailed Description:
The random stratification factors of this study are as follows:
* Disease stage: ⅢB/ⅢC stage vs Ⅳ stage;
* PD-L1 expression score indicator (tumor cell positive proportion score TPS): \<1%, 1%-49%, ≥50%;
* Hepatic metastasis or brain metastasis: Yes vs No. This study uses the RECIST v1.1 standard to conduct regular tumor response assessments for the subjects. Tumor assessment are conducted at the 6th week (±7 days), the 12th week (±7 days), and every 9 weeks thereafter (±7 days) within 48 weeks after the first administration of the drug; and every 12 weeks thereafter (±7 days). If the subject stops the study treatment due to reasons other than disease progression or death, the tumor assessment should continue according to the fixed schedule until imaging progression or termination of the study (the latter occurring is the criterion), initiation of new anti-tumor treatment, loss to follow-up, death, withdrawal of informed consent, or study completion, whichever occurs first. After the first imaging progression, if the investigator believes that the subject can still benefit from continued treatment and meets the criteria listed in the protocol for continuing treatment, the subject can continue with the original treatment plan until no clinical benefit is observed (assessed by the investigator). If the subject stops the study treatment for reasons other than the above (such as occurrence of intolerable adverse events, or the subject has received 24 months of HB0025 or pembrolizumab treatment, or other reasons for stopping treatment, etc.), a tumor assessment should be conducted before terminating the study. The investigator can conduct unplanned (with an interval of at least 4 weeks greater than the previous assessment) tumor assessments in cases of suspected disease progression or other necessary circumstances. The sponsor will collect all the imaging data of the subjects for BICR assessment.
* Disease stage: ⅢB/ⅢC stage vs Ⅳ stage;
* PD-L1 expression score indicator (tumor cell positive proportion score TPS): \<1%, 1%-49%, ≥50%;
* Hepatic metastasis or brain metastasis: Yes vs No. This study uses the RECIST v1.1 standard to conduct regular tumor response assessments for the subjects. Tumor assessment are conducted at the 6th week (±7 days), the 12th week (±7 days), and every 9 weeks thereafter (±7 days) within 48 weeks after the first administration of the drug; and every 12 weeks thereafter (±7 days). If the subject stops the study treatment due to reasons other than disease progression or death, the tumor assessment should continue according to the fixed schedule until imaging progression or termination of the study (the latter occurring is the criterion), initiation of new anti-tumor treatment, loss to follow-up, death, withdrawal of informed consent, or study completion, whichever occurs first. After the first imaging progression, if the investigator believes that the subject can still benefit from continued treatment and meets the criteria listed in the protocol for continuing treatment, the subject can continue with the original treatment plan until no clinical benefit is observed (assessed by the investigator). If the subject stops the study treatment for reasons other than the above (such as occurrence of intolerable adverse events, or the subject has received 24 months of HB0025 or pembrolizumab treatment, or other reasons for stopping treatment, etc.), a tumor assessment should be conducted before terminating the study. The investigator can conduct unplanned (with an interval of at least 4 weeks greater than the previous assessment) tumor assessments in cases of suspected disease progression or other necessary circumstances. The sponsor will collect all the imaging data of the subjects for BICR assessment.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: