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

NCT ID: NCT06136910

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2025-12-31

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.

Conditions

Untreated Advanced Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy

Intervention Type: DRUG

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.

Interventions

Recombinant 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liyun Miao, Doctor

Role: STUDY_CHAIR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Dongyong Yang, Bachelor

Role: STUDY_CHAIR

The Second Attached Hospital Of Fujian Medical University

Jianhong Xiao, Bachelor

Role: STUDY_CHAIR

MinDong Hospital of Ningde City

Minlin zheng, Bachelor

Role: STUDY_CHAIR

The Second Hospital of Zhangzhou

Locations

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiyong He, Master

Role: CONTACT

liyunmiao462@163.com

+8613805086391

Jinghui Lin, Bachelor

Role: CONTACT

2690213099@qq.com

+8613706990793

Facility Contacts

Zhiyong He, Master

Role: primary

liyunmiao462@163.com

+8613805086391

Jinghui Lin, Bachelor

Role: backup

2690213099@qq.com

+8613706990793

Other Identifiers

SCOG006

Identifier Type: -

Identifier Source: org_study_id