EGFR/ ALK-negative Advanced NSCLCPhase 2NCT06260553
Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC
A Phase 2 study testing tislelizumab and metronomic oral vinorelbine in people with EGFR/ ALK-negative Advanced NSCLC, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- EGFR/ ALK-negative Advanced NSCLC
- What is being tested?
- tislelizumab and metronomic oral vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2024to 7 Aug 2025
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer [AJCC] 8th edition) squamous NSCLC or non-squamous NSCLC without sensitising EGFR or ALK alterations.
- Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
- Has not received prior systemic treatment for metastatic NSCLC.
- Has a life expectancy of at least 3 months.
- Has fully understood this study and voluntarily signed a written informed consent form.
- Deemed unsuitable by the investigator for any platinum-doublet chemotherapy due to poor performance status (ECOG performance status of 2-3)；>= 75 years of age；substantial comorbidities; contraindication(s) for any platinum-doublet chemotherapy.
Who cannot join
- Histological or cytological confirmation of small cell lung cancer.
- Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has disorders of oral medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC Patients Intolerant to First-line Standard Chemotherapy: A Singlearm Phase Il Clinical Trial
To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy.
Read the detailed description
This study is a clinical intervention study. The patients who comfirm the criteria will be treated with tislelizumab plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated. Drug administration regimen: tislelizumab 200mg intravenous drip once every 3 week3; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
- Conditions
- EGFR/ ALK-negative Advanced NSCLC
- Being tested
- tislelizumab and metronomic oral vinorelbine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tislelizumab and metronomic oral vinorelbineDrug
tislelizumab 200mg intravenous drip once every three weeks; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
| Study group | Role | What they receive |
|---|---|---|
| tislelizumab plus metronomic oral vinorelbine | Experimental | Not described Receives: Drug: tislelizumab and metronomic oral vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (3)
ORR
Objective Response Rate
Measured: up to 12 months
DCR
Disease Control Rate
Measured: up to 12 months
AE
Number of Participants Who Experienced an Adverse Event
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start7 Feb 2024 (estimated)
- Primary completion7 Feb 2025 (estimated)
- Study completion7 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR/ ALK-negative Advanced NSCLCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260553
- Sponsor's protocol ID
- SCOG008
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC Patients Intolerant to First-line Standard Chemotherapy: A Singlearm Phase Il Clinical Trial
- ClinicalTrials.gov ID
- NCT06260553
- Acronym / sponsor ID
- SCOG008
- Conditions
- EGFR/ ALK-negative Advanced NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 7 Feb 2024 (estimated)
- Primary completion
- 7 Feb 2025 (estimated)
- Study completion
- 7 Aug 2025 (estimated)
- First posted
- 15 Feb 2024 (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.
To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy.
Detailed description
This study is a clinical intervention study. The patients who comfirm the criteria will be treated with tislelizumab plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated. Drug administration regimen: tislelizumab 200mg intravenous drip once every 3 week3; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tislelizumab plus metronomic oral vinorelbine | Experimental | Drug: tislelizumab and metronomic oral vinorelbine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer [AJCC] 8th edition) squamous NSCLC or non-squamous NSCLC without sensitising EGFR or ALK alterations.
- Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
- Has not received prior systemic treatment for metastatic NSCLC.
- Has a life expectancy of at least 3 months.
- Has fully understood this study and voluntarily signed a written informed consent form.
Key exclusion criteria (4 listed)
- Histological or cytological confirmation of small cell lung cancer.
- Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has disorders of oral medication.
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 |
|---|---|---|
| tislelizumab and metronomic oral vinorelbinetislelizumab 200mg intravenous drip once every three weeks; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course. | Drug | tislelizumab plus metronomic oral vinorelbine |
Primary outcome
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progression-free survival
3 secondary outcomes
ORR
Time frame: up to 12 months
DCR
Time frame: up to 12 months
AE
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tislelizumab and metronomic oral vinorelbine in people with EGFR/ ALK-negative Advanced NSCLC, 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 6 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 15 Feb 2024. 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). 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 15 Feb 2024.