Non-Small Cell Lung CancerPhase 2PROTECT-1NCT06929936
Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
A Phase 2 study testing Trilaciclib combined with Docetaxel in people with Non-Small Cell Lung Cancer and Myelosuppression, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
This study is a prospective, single arm phase II study aimed at patients with locally advanced or metastatic non-small cell lung cancer undergoing second-line or beyond treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Myelosuppression
- What is being tested?
- Trilaciclib combined with Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2025to Jun 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
- Patients must meet all of the following inclusion criteria to be included in this study:
- Age ≥ 18 years old, regardless of gender;
- Patients with stage IV NSCLC who have failed at least one line of standard treatment regimen:
- Patients with negative driver genes must have received first line standard treatment (chemotherapy combined with immunotherapy).
- Patients with positive driver genes must have received at least one line chemotherapy after standard targeted therapy has failed.
- Definition of driver genes: EGFR (including 19del, L858R, S768I, L861Q, and/or G719X), BRAF V600E, NTRK, MET14 exon skipping mutation, RET, ROS1, etc.
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- At least one measurable lesion that meets the RECIST 1.1 criteria exists;
- The laboratory test results meet 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 rate (CrCl) ≥ 60mL/min (Cockcroft Gault formula); Total bilirubin ≤ 1.5xupper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN or ≤ 5×ULN (for patients with liver metastases); Albumin ≥ 30 g/L;
- ECOG PS score 0-2;
- Expected survival time ≥ 3 months;
- Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the informed consent form until 3 months after the last dose;
- Understand and sign the informed consent form.
Who cannot join
- Previously received treatment with docetaxel;
- Diagnosed with malignant diseases other than NSCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ);
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
- Stroke or cardiovascular events within the first 6 months of enrollment;
- When screening, if the QTcF interval is greater than 480 milliseconds, for patients implanted with ventricular pacemakers, QTcF>500msec；
- Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infected individuals;
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- Previously received hematopoietic stem cell or bone marrow transplantation;
- Allergies to research drugs or their 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.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Wu, 86 592 2137611, 23889925@qq.com
About this study
Official title: Phase II Clinical Trial of Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This study is a prospective, single arm phase II study aimed at patients with locally advanced or metastatic non-small cell lung cancer undergoing second-line or beyond treatment. The aim is to evaluate the bone marrow protective effect of trilaciclib before docetaxel chemotherapy for locally advanced or metastatic NSCLC.
Read the detailed description
After obtaining informed consent from patients diagnosed with locally advanced or metastatic NSCLC through pathology, 33 eligible subjects who met the inclusion criteria were selected to receive the treatment regimen of trilaciclib before docetaxel chemotherapy, with a treatment period of 4 cycles.
Record the dynamic changes of whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Transfusion of blood products and supplementation of hematopoietic raw materials. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination shall be conducted within 21 days prior to the first administration, and tumor imaging evaluation shall be conducted every 6 weeks (± 7 days) from 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 the calendar day 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)
- Conditions
- Non-Small Cell Lung Cancer, Myelosuppression
- Being tested
- Trilaciclib combined with Docetaxel
- 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.
Trilaciclib combined with DocetaxelDrug
Trilaciclib: 240 mg/m2 as a 30-min iv. infusion, completed ≤4h prior to chemotherapy.
Docetaxel: 75mg/m2, iv. infusion for 1 hour on days 1 of each 21-day cycle, totaling 4 cycles of medication.
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib combined with Docetaxel | Experimental | Trilaciclib combined with Docetaxel Receives: Drug: Trilaciclib combined with Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥ 3 neutropenia during chemotherapy treatment
Measured: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Secondary outcomes (10)
Incidence rate of grade 3 or 4 thrombocytopenia
Measured: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Incidence rate of grade 3 or 4 anemia during chemotherapy treatment
Measured: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Incidence rate of febrile neutropenia
Measured: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Usage rate of symptomatic treatments for myelosuppression
such as granulocyte colony-stimulating factor (G-CSF) (not for prevention), thrombopoietin (TPO), interleukin-11 (IL-11), erythropoiesis-stimulating agents (ESA), iron supplements, etc
Measured: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Objective response rate
Measured: 12 months after the last subject participating in
Disease control rate
Measured: 12 months after the last subject participating in
Duration of response
Measured: 12 months after the last subject participating in
Progression-free survival
Measured: 12 months after the last subject participating in
Overall survival
Measured: From the date of randomization to the date of death for patients who died in the study due to any cause, or to the last contact date known to be alive for those who survived as of the data cutoff date, assessed up to 30 months.
Incidence rate of adverse events
Measured: Time from date of first dose of trilaciclib and docetaxel through 90 days following the last dose of trilaciclib and docetaxel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start9 May 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 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.
- 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929936
- Sponsor's protocol ID
- PROTECT-1
- Acronym
- PROTECT-1
- Status last verified
- May 2025
- First submitted
- 23 Mar 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06929936
- Acronym / sponsor ID
- PROTECT-1 / PROTECT-1
- Conditions
- Non-Small Cell Lung Cancer, Myelosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Apr 2025 (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 prospective, single arm phase II study aimed at patients with locally advanced or metastatic non-small cell lung cancer undergoing second-line or beyond treatment. The aim is to evaluate the bone marrow protective effect of trilaciclib before docetaxel chemotherapy for locally advanced or metastatic NSCLC.
Detailed description
After obtaining informed consent from patients diagnosed with locally advanced or metastatic NSCLC through pathology, 33 eligible subjects who met the inclusion criteria were selected to receive the treatment regimen of trilaciclib before docetaxel chemotherapy, with a treatment period of 4 cycles.
Record the dynamic changes of whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Transfusion of blood products and supplementation of hematopoietic raw materials. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination shall be conducted within 21 days prior to the first administration, and tumor imaging evaluation shall be conducted every 6 weeks (± 7 days) from 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 the calendar day 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)
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 Docetaxel | Experimental | Drug: Trilaciclib combined with DocetaxelTrilaciclib combined with Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years old, regardless of gender;
- Patients with stage IV NSCLC who have failed at least one line of standard treatment regimen:
- At least one measurable lesion that meets the RECIST 1.1 criteria exists;
- The laboratory test results meet 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 rate (CrCl) ≥ 60mL/min (Cockcroft Gault formula); Total bilirubin ≤ 1.5xupper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN or ≤ 5×ULN (for patients with liver metastases); Albumin ≥ 30 g/L;
Key exclusion criteria (9 listed)
- Previously received treatment with docetaxel;
- Diagnosed with malignant diseases other than NSCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ);
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
- Stroke or cardiovascular events within the first 6 months of enrollment;
- When screening, if the QTcF interval is greater than 480 milliseconds, for patients implanted with ventricular pacemakers, QTcF>500msec；
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 |
|---|---|---|
| Trilaciclib combined with DocetaxelTrilaciclib: 240 mg/m2 as a 30-min iv. infusion, completed ≤4h prior to chemotherapy. Docetaxel: 75mg/m2, iv. infusion for 1 hour on days 1 of each 21-day cycle, totaling 4 cycles of medication. | Drug | Trilaciclib combined with Docetaxel |
Primary outcome
Incidence of grade ≥ 3 neutropenia during chemotherapy treatment
Time frame: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
10 secondary outcomes
Incidence rate of grade 3 or 4 thrombocytopenia
Time frame: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Incidence rate of grade 3 or 4 anemia during chemotherapy treatment
Time frame: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Incidence rate of febrile neutropenia
Time frame: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Usage rate of symptomatic treatments for myelosuppression
Time frame: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Objective response rate
Time frame: 12 months after the last subject participating in
Disease control rate
Time frame: 12 months after the last subject participating in
Duration of response
Time frame: 12 months after the last subject participating in
Progression-free survival
Time frame: 12 months after the last subject participating in
Overall survival
Time frame: From the date of randomization to the date of death for patients who died in the study due to any cause, or to the last contact date known to be alive for those who survived as of the data cutoff date, assessed up to 30 months.
Incidence rate of adverse events
Time frame: Time from date of first dose of trilaciclib and docetaxel through 90 days following the last dose of trilaciclib and docetaxel
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 8 Jun 2025.
- Individual participant dataSharing planned: Yes
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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.
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 combined with Docetaxel in people with Non-Small Cell Lung Cancer and Myelosuppression, run by The First Affiliated Hospital of Xiamen University 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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Jun 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥ 3 neutropenia during chemotherapy treatment (time frame: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel). 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 8 Jun 2025.