To hear about similar clinical trials, please enter your email below
Trial Title:
Oncorine (H101) Combined With Tislelizumab and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer
NCT ID:
NCT06136910
Condition:
Untreated Advanced Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy
Description:
1. Recombinant human adenovirus type 5 injection : 21 days is one treatment cycle, in
principle, 4 cycles of administration, 1 injection on day 1 (d1) of each cycle; the
number of injections is determined according to the patient's tolerance and the ease
of operation of the injection site, no less than 2 times.
2. tirelizumab: 200mg intravenous, d1, Q21d, administered until disease progression or
intolerable side effects occur
3. platinum-containing two-drug chemotherapy: adenocarcinoma, pemetrexed combined with
carboplatin, 4-6 cycles, d2, Q21d; non-adenocarcinoma, paclitaxel/gemcitabine
combined with carboplatin, 4-6 cycles, d2, Q21d.
Arm group label:
H101 combined with tirilizumab and platinum-containing two-drug chemotherapy
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.
Detailed description:
Phase 1 is a preliminary exploration of safety and efficacy. The safety and efficacy of
the regimen was assessed in the 10 patients enrolled for interim analysis. Phase 2 will
continue to expand the sample size to assess the efficacy and safety of the regimen, with
20 patients planned to be enrolled.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Fully informed about the study and voluntarily signed an informed consent form
(ICF); ≥18 years and ≤75 years;
2. ECOG score 0-1;
3. non-small cell lung cancer (NSCLC) confirmed by histology or pathology;
4. stage IV on imaging assessment;
5. no EGFR or ALK gene mutations (genetic testing may not be performed in patients with
squamous lung cancer);
6. no previous antitumour treatment for NSCLC No prior antitumour therapy for NSCLC;
7. lesions suitable for intratumour injection of drugs;
8. measurable or assessable lesions according to RECIST 1.1 criteria.
Exclusion Criteria:
1. histological or cytological pathology of the tumour confirms a combined small cell
lung cancer component;
2. those with tests suggesting severe organ dysfunction;
3. subjects with any active, known or suspected autoimmune disease are excluded;
4. expected survival is less than 3 months.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiyong He, Master
Phone:
+8613805086391
Email:
liyunmiao462@163.com
Contact backup:
Last name:
Jinghui Lin, Bachelor
Phone:
+8613706990793
Email:
2690213099@qq.com
Start date:
May 9, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136910
