Oncorine (H101) Combined With Tislelizumab and Platinum-based Two-drug Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer, a Phase II Single-arm Clinical Trail
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is a single-arm, single-centre phase II study to evaluate the efficacy (PFS, ORR, DCR) and safety of recombinant human adenovirus type 5 in combination with tirelizumab and platinum-containing dual-agent chemotherapy in previously untreated patients with advanced non-small cell lung cancer who are EGFR/ALK negative. The study is divided into 2 phases.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Fully informed about the study and voluntarily signed an informed consent form (ICF); ≥18 years and ≤75 years;
• ECOG score 0-1;
• non-small cell lung cancer (NSCLC) confirmed by histology or pathology;
• stage IV on imaging assessment;
• no EGFR or ALK gene mutations (genetic testing may not be performed in patients with squamous lung cancer);
• no previous antitumour treatment for NSCLC No prior antitumour therapy for NSCLC;
• lesions suitable for intratumour injection of drugs;
• measurable or assessable lesions according to RECIST 1.1 criteria.
Locations
Other Locations
China
Fujian Cancer Hospital
RECRUITING
Fuzhou
Contact Information
Primary
Zhiyong He, Master
liyunmiao462@163.com
+8613805086391
Backup
Jinghui Lin, Bachelor
2690213099@qq.com
+8613706990793
Time Frame
Start Date:2023-05-09
Estimated Completion Date:2025-12-31
Participants
Target number of participants:30
Treatments
Experimental: H101 combined with tirilizumab and platinum-containing two-drug chemotherapy
1. Recombinant human adenovirus type 5 injection(H101), intratumoural, administered for 4 cycles, 1 injection on day 1 (d1) of each cycle.The number of injections should be determined according to the patient's tolerance and the ease of manipulation of the injection site, and should be no less than 2 times.~2. Tirilizumab injection, 200 mg, IV, d1, Q21d, administered until disease progression or intolerable side effects occur~3. Platinum-containing two-agent chemotherapy Adenocarcinoma: pemetrexed plus carboplatin Non-adenocarcinoma: paclitaxel/gemcitabine combined with carboplatin