Non-small Cell Lung CancerPhase 2NCT06370416
the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib
A Phase 2 study testing Trilaciclib in people with Non-small Cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Trilaciclib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2024to 31 Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old, regardless of gender;
- Patients with locally advanced and late stage (IIIB, IIIC, IV) NSCLC who have been confirmed by histopathology and cannot be surgically removed (without local symptoms (with or without brain metastasis)) have at least one measurable lesion that meets the RECIST 1.1 criteria
- Need to receive chemotherapy treatment (first-line chemotherapy treatment uses platinum+pemetrexed/docetaxel/albumin paclitaxel/paclitaxel; second-line chemotherapy treatment: choose the above first-line chemotherapy treatment without using chemotherapy drugs; (Note: If first-line chemotherapy treatment does not combine with immunotherapy, subsequent increase in immunotherapy patients will not be counted as an increase in the number of treatment lines, and the number of treatment lines in this trial is limited to the number of chemotherapy treatment lines)
- The laboratory inspection meets the standards
- ECOG PS score 0-1 points;
- Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and reliable contraceptive measures must be taken 3 months after signing the informed consent form and the last dose;
- Understand and sign the informed consent form.
Who cannot join
- Diagnosed as other malignant diseases other than NSCLC within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ);
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV);
- Stroke or cardiovascular events within 6 months prior to enrollment
- When screening, QTcF interval>480msec, for patients with implanted ventricular pacemakers, QTcF>500msec
- Previously received hematopoietic stem cell or bone marrow transplantation
- Allergy to the investigational drug or its components;
- The researchers believe that it is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single Arm, Exploratory Clinical Study on the Prevention of Bone Marrow Suppression Caused by Platinum Containing Chemotherapy in Advanced Non-small Cell Lung Cancer With Trilaciclib
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.
Read the detailed description
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with non-small cell lung cancer(NSCLC).After pathological diagnosis of NSCLC, 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.Record the dynamic changes in whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Blood product infusion and supplementation of hematopoietic raw materials; The use of hematopoietic growth factors; Systemic use of antibiotics; Score the EQ-5D-5L, FACT-L, and FACT-An scales. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination should be conducted within 21 days prior to the first administration, and tumor imaging evaluation should be conducted every 6 weeks (± 7 days) since the first study drug administration, or the frequency of imaging evaluation may be increased when there are clinical indications. The imaging examination time should follow calendar days and should not be adjusted due to treatment delay or termination. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons should continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest) Researchers will monitor potential adverse events (AEs) throughout the entire trial and grade the severity of adverse events according to the guidelines of the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0. After treatment, the subjects will undergo a 30 day safety follow-up to monitor AE. If the patient does not receive new anti-tumor treatment within 90 days after the last medication, serious adverse events (SAEs) within 90 days after the last medication will be collected. If the subject begins new anti-tumor treatment, SAEs before starting new anti-tumor treatment will be collected, whichever occurs first.
This study will be conducted in accordance with Good Clinical Practice for Drugs (GCP).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Trilaciclib
- Keywords
- Non-small cell lung cancer（NSCLC）, trilaciclib, Bone marrow protection, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Also called Trilaciclib Injection
After pathological diagnosis of NSCLC, 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib group | Experimental | 240mg/m2, intravenous infusion for 30 minutes, and administration completed within 4 hours before daily chemotherapy; Receives: Drug: Trilaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
Neutrophils ≤ 1.0*109
Measured: 1-2 weeks after chemotherapy
Secondary outcomes (3)
The incidence of grade 4 neutropenia during chemotherapy treatment
Neutrophils ≤ 0.5*109
Measured: 1-2 weeks after chemotherapy
The incidence of grade 3 or grade 4 thrombocytopenia
Platelets≤ 50*109
Measured: 1-2 weeks after chemotherapy
The incidence of grade 3 or 4 anemia during chemotherapy treatment
hemoglobin<80g/L
Measured: 1-3 weeks after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start2 Apr 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Henan 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yanqiu Zhao, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370416
- Sponsor's protocol ID
- HSKY002
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Exploratory Clinical Study on the Prevention of Bone Marrow Suppression Caused by Platinum Containing Chemotherapy in Advanced Non-small Cell Lung Cancer With Trilaciclib
- ClinicalTrials.gov ID
- NCT06370416
- Acronym / sponsor ID
- HSKY002
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer（NSCLC）, trilaciclib, Bone marrow protection, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 17 Apr 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.
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.
Detailed description
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with non-small cell lung cancer(NSCLC).After pathological diagnosis of NSCLC, 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.Record the dynamic changes in whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Blood product infusion and supplementation of hematopoietic raw materials; The use of hematopoietic growth factors; Systemic use of antibiotics; Score the EQ-5D-5L, FACT-L, and FACT-An scales. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination should be conducted within 21 days prior to the first administration, and tumor imaging evaluation should be conducted every 6 weeks (± 7 days) since the first study drug administration, or the frequency of imaging evaluation may be increased when there are clinical indications. The imaging examination time should follow calendar days and should not be adjusted due to treatment delay or termination. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons should continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest) Researchers will monitor potential adverse events (AEs) throughout the entire trial and grade the severity of adverse events according to the guidelines of the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0. After treatment, the subjects will undergo a 30 day safety follow-up to monitor AE. If the patient does not receive new anti-tumor treatment within 90 days after the last medication, serious adverse events (SAEs) within 90 days after the last medication will be collected. If the subject begins new anti-tumor treatment, SAEs before starting new anti-tumor treatment will be collected, whichever occurs first.
This study will be conducted in accordance with Good Clinical Practice for Drugs (GCP).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib group | Experimental | Drug: Trilaciclib240mg/m2, intravenous infusion for 30 minutes, and administration completed within 4 hours before daily chemotherapy; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old, regardless of gender;
- Patients with locally advanced and late stage (IIIB, IIIC, IV) NSCLC who have been confirmed by histopathology and cannot be surgically removed (without local symptoms (with or without brain metastasis)) have at least one measurable lesion that meets the RECIST 1.1 criteria
- Need to receive chemotherapy treatment (first-line chemotherapy treatment uses platinum+pemetrexed/docetaxel/albumin paclitaxel/paclitaxel; second-line chemotherapy treatment: choose the above first-line chemotherapy treatment without using chemotherapy drugs; (Note: If first-line chemotherapy treatment does not combine with immunotherapy, subsequent increase in immunotherapy patients will not be counted as an increase in the number of treatment lines, and the number of treatment lines in this trial is limited to the number of chemotherapy treatment lines)
- The laboratory inspection meets the standards
- ECOG PS score 0-1 points;
Key exclusion criteria (7 listed)
- Diagnosed as other malignant diseases other than NSCLC within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ);
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV);
- Stroke or cardiovascular events within 6 months prior to enrollment
- When screening, QTcF interval>480msec, for patients with implanted ventricular pacemakers, QTcF>500msec
- Previously received hematopoietic stem cell or bone marrow transplantation
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 InjectionAfter pathological diagnosis of NSCLC, 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent. | Drug | Trilaciclib group |
Primary outcome
The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
Time frame: 1-2 weeks after chemotherapy
Neutrophils ≤ 1.0*109
3 secondary outcomes
The incidence of grade 4 neutropenia during chemotherapy treatment
Time frame: 1-2 weeks after chemotherapy
The incidence of grade 3 or grade 4 thrombocytopenia
Time frame: 1-2 weeks after chemotherapy
The incidence of grade 3 or 4 anemia during chemotherapy treatment
Time frame: 1-3 weeks after chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- 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.
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 Trilaciclib in people with Non-small Cell Lung Cancer, run by Henan 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 7 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 28 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The incidence of grade ≥ 3 neutropenia during chemotherapy treatment (time frame: 1-2 weeks after chemotherapy). 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 28 Jan 2026.