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

Sponsor

Fujian Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06136910

Collaborator

(none)

Enrollment

Location

Arm

31.8

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Untreated Advanced Non-small Cell Lung Cancer	Drug: Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 9, 2023

Anticipated Primary Completion Date :

May 9, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: H101 combined with tirilizumab and platinum-containing two-drug chemotherapy 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. Tirilizumab injection, 200 mg, IV, d1, Q21d, administered until disease progression or intolerable side effects occur Platinum-containing two-agent chemotherapy Adenocarcinoma: pemetrexed plus carboplatin Non-adenocarcinoma: paclitaxel/gemcitabine combined with carboplatin	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.

Arm

Intervention/Treatment

Experimental: H101 combined with tirilizumab and platinum-containing two-drug chemotherapy

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. Tirilizumab injection, 200 mg, IV, d1, Q21d, administered until disease progression or intolerable side effects occur Platinum-containing two-agent chemotherapy Adenocarcinoma: pemetrexed plus carboplatin Non-adenocarcinoma: paclitaxel/gemcitabine combined with carboplatin

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

histological or cytological pathology of the tumour confirms a combined small cell lung cancer component;
those with tests suggesting severe organ dysfunction;
subjects with any active, known or suspected autoimmune disease are excluded;
expected survival is less than 3 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Cancer Hospital	Fuzhou	Fujian	China

Sponsors and Collaborators

Fujian Cancer Hospital

Investigators

Study Chair: Liyun Miao, Doctor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Chair: Dongyong Yang, Bachelor, The Second Attached Hospital Of Fujian Medical University
Study Chair: Jianhong Xiao, Bachelor, MinDong Hospital of Ningde City
Study Chair: Minlin zheng, Bachelor, The Second Hospital of Zhangzhou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fujian Cancer Hospital

ClinicalTrials.gov Identifier:

NCT06136910

Other Study ID Numbers:

SCOG006

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Nov 18, 2023