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

November 13, 2023 updated by: Fujian Cancer Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The time from the date of first treatment to the first occurrence of disease progression or death from any cause, whichever event occurs first.
Time Frame: 1 year
Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of CR and PR in all patients.
Time Frame: 1 year
Objective response rate: ORR
1 year
Proportion of CR, PR and SD in all patients.
Time Frame: 1 year
Disease control rate: DCR
1 year
Safety statistics will be analysed for adverse events.
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Cancer Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCOG006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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