MyelosuppressionPhase 2NCT06490081
Trilaciclib Prevents Myelosuppression With Chemoradiotherapy
A Phase 2 study testing Trilaciclib in people with Myelosuppression, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Myelosuppression
- What is being tested?
- Trilaciclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2024to 30 Jun 2026
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The histopathology is limited-stage small cell lung cancer.
- ECOG score 0-2.
- Good organ function (no blood transfusions, no hematopoietic stimulating factors, no transfusions of albumin or blood products within 14 days prior to the examination).
- It is suitable for patients treated with Trilaciclib combined with etoposide plus cisplatin or carboplatin.
- Understand and can sign informed consent
Who cannot join
- Brain metastases with clinical symptoms require local radiotherapy or hormone therapy.
- Active infections require systemic treatment.
- Subjects with active, known or suspected autoimmune disease or history of autoimmune disease.
- Combined with other tumors.
- The current or previous presence of a clinically significant and medically unstable condition, which in the investigator's professional judgment may compromise subject safety, interfere with study evaluation or endpoint assessment, or otherwise impact the reliability of study results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Lei Deng, PhD
About this study
Official title: To Evaluate the Protective Effect of Trilaciclib on Myelosuppression in Patients With Limited-stage Small Cell Lung Cancer Associated With Concurrent Chemoradiotherapy and Discuss the Effect of Gut Microbiota Changes on Myelosuppression
To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression
Read the detailed description
The occurrence of myelosuppression following chemotherapy, including severe neutropenia and hematological toxicity (Grade 3/4), as well as its association with dynamic changes in the gut microbiota, was investigated in conjunction with prophylactic administration of the CDK4/6 inhibitor Trilaciclib prior to the initiation of chemotherapy during radiotherapy for limited stage small cell lung cancer.
- Conditions
- Myelosuppression
- Being tested
- Trilaciclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Also called Trilaciclib combined with concurrent chemoradiotherapy
During concurrent chemoradiotherapy in limited-stage small cell lung cancer, Trilaciclib is administered prophylactically before the first cycle of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib combined with concurrent chemoradiotherapy | Experimental | Trilaciclib is used simultaneously before the first cycle of chemotherapy during radiotherapy for limited-stage small cell lung cancer Receives: Drug: Trilaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of severe neutropenia
Grade 3/4 decline in neutropenia after the first cycle of chemotherapy during radiotherapy
Measured: 14 days
Duration of severe neutropenia
Duration of severe neutropenia after the first cycle of chemotherapy during radiotherapy (ANC<1.0×10^9/L for more than 5 days)
Measured: 5 days
Occurrence of hematological toxicity
Grade 3/4 decline in neutrophils, platelets, and red blood cells
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start26 Jun 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelosuppressionStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Deng, PhD, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490081
- Sponsor's protocol ID
- NCC4382
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Protective Effect of Trilaciclib on Myelosuppression in Patients With Limited-stage Small Cell Lung Cancer Associated With Concurrent Chemoradiotherapy and Discuss the Effect of Gut Microbiota Changes on Myelosuppression
- ClinicalTrials.gov ID
- NCT06490081
- Acronym / sponsor ID
- NCC4382
- Conditions
- Myelosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Jul 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 protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression
Detailed description
The occurrence of myelosuppression following chemotherapy, including severe neutropenia and hematological toxicity (Grade 3/4), as well as its association with dynamic changes in the gut microbiota, was investigated in conjunction with prophylactic administration of the CDK4/6 inhibitor Trilaciclib prior to the initiation of chemotherapy during radiotherapy for limited stage small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib combined with concurrent chemoradiotherapy | Experimental | Drug: TrilaciclibTrilaciclib is used simultaneously before the first cycle of chemotherapy during radiotherapy for limited-stage small cell lung cancer |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The histopathology is limited-stage small cell lung cancer.
- ECOG score 0-2.
- Good organ function (no blood transfusions, no hematopoietic stimulating factors, no transfusions of albumin or blood products within 14 days prior to the examination).
- It is suitable for patients treated with Trilaciclib combined with etoposide plus cisplatin or carboplatin.
- Understand and can sign informed consent
Key exclusion criteria (5 listed)
- Brain metastases with clinical symptoms require local radiotherapy or hormone therapy.
- Active infections require systemic treatment.
- Subjects with active, known or suspected autoimmune disease or history of autoimmune disease.
- Combined with other tumors.
- The current or previous presence of a clinically significant and medically unstable condition, which in the investigator's professional judgment may compromise subject safety, interfere with study evaluation or endpoint assessment, or otherwise impact the reliability of study results.
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 |
|---|---|---|
| TrilaciclibAlso: Trilaciclib combined with concurrent chemoradiotherapyDuring concurrent chemoradiotherapy in limited-stage small cell lung cancer, Trilaciclib is administered prophylactically before the first cycle of chemotherapy | Drug | Trilaciclib combined with concurrent chemoradiotherapy |
Primary outcome
Occurrence of severe neutropenia
Time frame: 14 days
Grade 3/4 decline in neutropenia after the first cycle of chemotherapy during radiotherapy
Duration of severe neutropenia
Time frame: 5 days
Duration of severe neutropenia after the first cycle of chemotherapy during radiotherapy (ANC<1.0×10^9/L for more than 5 days)
Occurrence of hematological toxicity
Time frame: 5 days
Grade 3/4 decline in neutrophils, platelets, and red blood cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Related trials for Myelosuppression
Active, not recruitingPhase 3
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Active, not recruitingPhase 4
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
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Dynamic Risk Prediction of Severe Myelosuppression in Nasopharyngeal Carcinoma
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Not yet recruiting
A Single-arm, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy and Safety of Trilaciclib in Preventing Myelosuppression Caused by Topoisomerase I Inhibitor Type ADC Drugs
Tumor Patients
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.
Lei Deng, PhD study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Trilaciclib in people with Myelosuppression, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 5 inclusion and 5 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 24 Sep 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 Xinrong Lian (010-87787692, 15810538030@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of severe neutropenia (time frame: 14 days). The study lists 3 primary outcomes in all. 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 24 Sep 2024.