Oncorine (H101) Combined With Tislelizumab and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer

Untreated Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136910
• Other study ID #: SCOG006
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 9, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Fujian Cancer Hospital
• Contact: Zhiyong He, Master
• Phone: +8613805086391
• Email: liyunmiao462[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: May 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Untreated Advanced Non-small Cell Lung Cancer

Intervention

Drug:
• Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy
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. tirelizumab: 200mg intravenous, d1, Q21d, administered until disease progression or intolerable side effects occur 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.

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time from the date of first treatment to the first occurrence of disease progression or death from any cause, whichever event occurs first.	Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria	1 year
Secondary	Proportion of CR and PR in all patients.	Objective response rate: ORR	1 year
Secondary	Proportion of CR, PR and SD in all patients.	Disease control rate: DCR	1 year
Secondary	Safety statistics will be analysed for adverse events.	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.	1 year