Extensive-stage Small-cell Lung CancerPhase 4NCT05071703
Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study
A Phase 4 study testing Trilaciclib in people with Extensive-stage Small-cell Lung Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Trilaciclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2021to 30 Nov 2022
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign informed consent;
- must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender:
- Patients with extensive small-cell lung cancer confirmed by histology or cytology
- Patients suitable for Trilaciclib combined with platinum/etoposide or Trilaciclib combined with topotecan treatment
Who cannot join
- Patient is currently participating in other Interventional clinical studies;
- Patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 During Trilaciclib treatment.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to participate in the study. Data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. The end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Trilaciclib
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Also called Trilaciclib, carboplatin, etoposide#or Topotecan
- Carboplatin combined with Etoposide (ES-SCLC patients)
- plus Topotecan (second/third line ES-SCLC patients)
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib, carboplatin, etoposide, Topotecan | Experimental | Trilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients) Receives: Drug: Trilaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe neutropenia (SN)
Incidence of severe neutropenia (SN)
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Secondary outcomes (18)
Incidence of grade 3 and 4 hematologic toxicity
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of intravenous or oral antibiotic administration in treatment
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of G-CSF treatment
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of red blood cell (RBC) transfusions at or after week 5
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of ESA administration in treatment
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of TPO administration in treatment
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of platelet transfusion
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
The number and frequency of all-caused chemotherapy drugs reduction
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
composite end point - Significant hematologic adverse event (occurrence of any of the following events：all-cause hospitalization; all-cause dose reduction; Febrile neutropenia; Severe neutropenia )
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of infectious serious adverse events
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of pulmonary infection serious adverse events
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of febrile neutropenia
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Objective response rate
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
duration of response
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Progression-free survival time
Measured: during Trilaciclib plus chemotherapy assessed up to 6 months
Disease control rate
Measured: during chemotherapy assessed up to 6 months
verall survival
Measured: maximun up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start11 Aug 2021
- Primary completion10 Apr 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- G1 Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Yongxing Chen, Principal investigator, Hainan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071703
- Sponsor's protocol ID
- Trila-CN-RWS-001
- Status last verified
- Sep 2021
- First submitted
- 28 Sep 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study
- ClinicalTrials.gov ID
- NCT05071703
- Acronym / sponsor ID
- Trila-CN-RWS-001
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- G1 Therapeutics, Inc.
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Oct 2021 (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, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to participate in the study. Data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. The end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib, carboplatin, etoposide, Topotecan | Experimental | Drug: TrilaciclibTrilaciclib plus Carboplatin combined with Etoposide OR Topotecan (ES-SCLC patients) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily participate and sign informed consent;
- must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender:
- Patients with extensive small-cell lung cancer confirmed by histology or cytology
- Patients suitable for Trilaciclib combined with platinum/etoposide or Trilaciclib combined with topotecan treatment
Key exclusion criteria (2 listed)
- Patient is currently participating in other Interventional clinical studies;
- Patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 During Trilaciclib treatment.
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, carboplatin, etoposide#or Topotecan* Carboplatin combined with Etoposide (ES-SCLC patients) * plus Topotecan (second/third line ES-SCLC patients) | Drug | Trilaciclib, carboplatin, etoposide, Topotecan |
Primary outcome
Incidence of severe neutropenia (SN)
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of severe neutropenia (SN)
18 secondary outcomes
Incidence of grade 3 and 4 hematologic toxicity
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of intravenous or oral antibiotic administration in treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of G-CSF treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of red blood cell (RBC) transfusions at or after week 5
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of ESA administration in treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of TPO administration in treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of platelet transfusion
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The number and frequency of all-caused chemotherapy drugs reduction
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
composite end point - Significant hematologic adverse event (occurrence of any of the following events：all-cause hospitalization; all-cause dose reduction; Febrile neutropenia; Severe neutropenia )
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of infectious serious adverse events
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of pulmonary infection serious adverse events
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of febrile neutropenia
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Objective response rate
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
duration of response
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Progression-free survival time
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Disease control rate
Time frame: during chemotherapy assessed up to 6 months
verall survival
Time frame: maximun up to 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 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.
Yongxing Chen principal investigator
Hainan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trilaciclib in people with Extensive-stage Small-cell Lung Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 6 Oct 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of severe neutropenia (SN) (time frame: during Trilaciclib plus chemotherapy assessed up to 6 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 6 Oct 2023.