NSCLCPhase 2NCT06332287
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis
A Phase 2 study testing combination of Trilaciclib and Pemetrexed in people with NSCLC, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
Trial summary
To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- combination of Trilaciclib and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender；
- ECOG-PS score of 0-1，and no worsening in the 2 weeks before the study drug；
- expected survival≥12 weeks；
- Advanced non-small cell lung cancer with leptomeningeal metastasis；
- with an Ommaya sac has been implanted；
- At least one measurable lesion meeting RECIST1.1 criteria was present；
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- Laboratory tests met the following criteria: hemoglobin ≥100 g/L (female), 110g/L (male) ；neutrophil count ≥ 2×109/L ；platelet count ≥100×109/L; Creatinine ≤ 15mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Total bilirubin ≤ 1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or 5× ULN (for patients with liver metastases); Albumin ≥ 30 g/L;
- Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
- Voluntarily participate and sign informed consent;
Who cannot join
- Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
- Stroke or cardio-cerebrovascular event within 6 months before enrollment;
- QTcF interval > 480msec at screening, QTcF > 500msec for patients with implanted ventricular pacemakers;
- Previous hematopoietic stem cell or bone marrow transplantation;
- Allergy to the study drug or its components;
- If the investigator considers that it is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fang Shencun
Suzhou, Jiangsu, 210029
fang S cun, M.D., 83728558 ext. 025, fang1984@aliyun.com
About this study
Official title: A Prospective, Single-arm, and Exploratory Phase II Clinical Study of Trilaciclib Combined With Lateral Ventricular Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer With Leptomeningeal Metastasis
To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。
Read the detailed description
A single-arm, open-label, interventional study was conducted in 25 NSCLC patients with leptomeningeal metastases to observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastases, and to evaluate the incidence and duration of severe neutropenia in the first cycle.
- Conditions
- NSCLC
- Being tested
- combination of Trilaciclib and Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of Trilaciclib and PemetrexedDrug
Also called G1T28, CDK 4/6 inhibitor
This was a single-arm, exploratory study of the combination of Trilaciclib and Pemetrexed in patients with non-small cell lung cancer with leptomeningeal metastasis. Observed the incidence of chemotherapy-induced myelosuppression, and imaging was performed every six cycles to assess tumor response.
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib+Pemetrexed | Experimental | Patients were treated with Trilaciclib (240mg/m2, administered within 4 hours before each chemotherapy,Q3W) and pemetrexed (30mg,Q3W) until disease progression as assessed by the investigator according to RECIST 1.1 criteria or withdrawal or discontinuation criteria were met. Receives: Drug: combination of Trilaciclib and Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of severe neutropenia (DSN)
Duration of severe neutropenia in cycle 1
Measured: During Trilaciclib plus chemotherapy assessed up to 21 days
Secondary outcomes (4)
Incidence of Treatment-Emergent Adverse Events
Occurrence and severity of AEs by NCI CTCAE v5.0
Measured: Up to 2 years
Incidence of grade 3 and 4 hematologic toxicity
Incidence of grade 3 and 4 hematologic toxicity
Measured: during Trilaciclib plus chemotherapy assessed up to 1 years
Incidence of G-CSF treatment
Incidence of G-CSF treatment
Measured: during Trilaciclib plus chemotherapy assessed up to 1 years
Incidence of platelet transfusion
Incidence of platelet transfusion
Measured: during Trilaciclib plus chemotherapy assessed up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 May 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- Model description
- Trilaciclib
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fang S cun, M.D., Study director, Nanjing Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332287
- Sponsor's protocol ID
- 2023-NSCLC
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 27 Mar 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, and Exploratory Phase II Clinical Study of Trilaciclib Combined With Lateral Ventricular Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer With Leptomeningeal Metastasis
- ClinicalTrials.gov ID
- NCT06332287
- Acronym / sponsor ID
- 2023-NSCLC
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 27 Mar 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 observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。
Detailed description
A single-arm, open-label, interventional study was conducted in 25 NSCLC patients with leptomeningeal metastases to observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastases, and to evaluate the incidence and duration of severe neutropenia in the first cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Trilaciclib
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib+Pemetrexed | Experimental | Drug: combination of Trilaciclib and PemetrexedPatients were treated with Trilaciclib (240mg/m2, administered within 4 hours before each chemotherapy,Q3W) and pemetrexed (30mg,Q3W) until disease progression as assessed by the investigator according to RECIST 1.1 criteria or withdrawal or discontinuation criteria were met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender；
- ECOG-PS score of 0-1，and no worsening in the 2 weeks before the study drug；
- expected survival≥12 weeks；
- Advanced non-small cell lung cancer with leptomeningeal metastasis；
- with an Ommaya sac has been implanted；
Key exclusion criteria (6 listed)
- Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
- Stroke or cardio-cerebrovascular event within 6 months before enrollment;
- QTcF interval > 480msec at screening, QTcF > 500msec for patients with implanted ventricular pacemakers;
- Previous hematopoietic stem cell or bone marrow transplantation;
- Allergy to the study drug or its components;
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 |
|---|---|---|
| combination of Trilaciclib and PemetrexedAlso: G1T28, CDK 4/6 inhibitorThis was a single-arm, exploratory study of the combination of Trilaciclib and Pemetrexed in patients with non-small cell lung cancer with leptomeningeal metastasis. Observed the incidence of chemotherapy-induced myelosuppression, and imaging was performed every six cycles to assess tumor response. | Drug | Trilaciclib+Pemetrexed |
Primary outcome
Duration of severe neutropenia (DSN)
Time frame: During Trilaciclib plus chemotherapy assessed up to 21 days
Duration of severe neutropenia in cycle 1
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 2 years
Incidence of grade 3 and 4 hematologic toxicity
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
Incidence of G-CSF treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
Incidence of platelet transfusion
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
fang S cun, M.D. study director
Nanjing Brain Hospital
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 combination of Trilaciclib and Pemetrexed in people with NSCLC, run by Jiangsu Province Nanjing Brain 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 9 inclusion and 6 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 27 Mar 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?
Contact fang S cun, M.D. (83728558 ext. 025, fang1984@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of severe neutropenia (DSN) (time frame: During Trilaciclib plus chemotherapy assessed up to 21 days). 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 27 Mar 2024.