Untreated Advanced Non-small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DRUGRecombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy
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.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time from the date of first treatment to the first occurrence of disease progression or death from any cause, whichever event occurs first. | 1 year | Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of CR and PR in all patients. | 1 year | Objective response rate: ORR |
| Proportion of CR, PR and SD in all patients. | 1 year | Disease control rate: DCR |
| Safety statistics will be analysed for adverse events. | 1 year | Safety statistics will be analysed for adverse events, including AEs, SAEs, drug-related AEs, AEs leading to dose adjustments, and AEs leading to withdrawal from the trial.All adverse events will also be rated based on the NCI CTCAE version 5.0, and AEs greater than or equal to grade 3 will be statistically summarised. |
Countries
China
Contacts
Primary ContactZhiyong He, Master
Backup ContactJinghui Lin, Bachelor
Outcome results
None listed