Untreated Advanced Non-small Cell Lung CancerPhase 1/2NCT06136910
Oncorine (H101) Combined With Tislelizumab and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer
A Phase 1/2 study testing Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy in people with Untreated Advanced Non-small Cell Lung Cancer, run by Fujian Cancer Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Untreated Advanced Non-small Cell Lung Cancer
- What is being tested?
- Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2023to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Zhiyong He, Master, +8613805086391, liyunmiao462@163.com
Jinghui Lin, Bachelor, +8613706990793, 2690213099@qq.com
About this study
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
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.
Read the 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.
- Being tested
- Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapyDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| H101 combined with tirilizumab and platinum-containing two-drug chemotherapy | Experimental | 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 Receives: Drug: Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Proportion of CR and PR in all patients.
Objective response rate: ORR
Measured: 1 year
Proportion of CR, PR and SD in all patients.
Disease control rate: DCR
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start9 May 2023
- Primary completion9 May 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Untreated Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Liyun Miao, Doctor, Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolDongyong Yang, Bachelor, Study chair, The Second Attached Hospital Of Fujian Medical UniversityJianhong Xiao, Bachelor, Study chair, MinDong Hospital of Ningde CityMinlin zheng, Bachelor, Study chair, The Second Hospital of Zhangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136910
- Sponsor's protocol ID
- SCOG006
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06136910
- Acronym / sponsor ID
- SCOG006
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 9 May 2023 (actual)
- Primary completion
- 9 May 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H101 combined with tirilizumab and platinum-containing two-drug chemotherapy | Experimental | Drug: Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy1. 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy1. 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. | Drug | H101 combined with tirilizumab and platinum-containing two-drug chemotherapy |
Primary outcome
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
3 secondary outcomes
Proportion of CR and PR in all patients.
Time frame: 1 year
Proportion of CR, PR and SD in all patients.
Time frame: 1 year
Safety statistics will be analysed for adverse events.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liyun Miao, Doctor study chair
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Dongyong Yang, Bachelor study chair
The Second Attached Hospital Of Fujian Medical University
Jianhong Xiao, Bachelor study chair
MinDong Hospital of Ningde City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy in people with Untreated Advanced Non-small Cell Lung Cancer, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong He, Master (+8613805086391, liyunmiao462@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.