NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2PROTECT-2NCT06992739
Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Trilaciclib and Sacituzumab Tirumotecan in people with NSCLC (Advanced Non-small Cell Lung Cancer) and EGFR, 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 clinical trial aimed at patients with advanced non-small cell lung cancer resistant to EGFR-TKI. The aim is to evaluate the efficacy and safety of trilaciclib in bone marrow protection before monotherapy with sacituzumab tirumotecan. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer), EGFR, Myelosuppression
- What is being tested?
- Trilaciclib and Sacituzumab Tirumotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to Dec 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18-75 years old; No gender restrictions;
- ECOG PS score 0-1;
- Expected survival time ≥ 3 months;
- Patients with locally advanced or metastatic EGFR mutant non-small cell lung cancer diagnosed by histological or cytological examination, who have failed third-generation EGFR-TKI treatment and have experienced up to second-line EGFR-TKI treatment failure;
- Patients who have only progressed with 1-2 generations of EGFR-TKI treatment need to undergo third-generation EGFR-TKI treatment;
- If patients receive third-generation EGFR-TKI during neoadjuvant and/or postoperative adjuvant therapy and progress to metastatic or locally advanced disease more than 6 months after the last dose, they need to receive third-generation EGFR-TKI treatment again before they can participate in this study;
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- If patients receive third-generation EGFR-TKI during neoadjuvant and/or postoperative adjuvant therapy and progress to metastatic or locally advanced disease within 6 months after the last dose, they can directly participate in this study;
- Imaging disease progression was recorded during or after the recent first-line treatment process.
- There must be at least one measurable lesion that meets the RECIST 1.1 criteria;
- The main organ functions well and meets the following standards:
- Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 80 × 109/L; Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome subjects, ≤ 3×ULN）； Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 60mL/min; Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;
- The subject must recover from all toxic reactions (except hair loss) of previous treatment to ≤ level 1 (evaluated based on CTCAE 5.0 criteria);
- 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;
- Participants voluntarily participate in this study, understand and sign the informed consent form.
Who cannot join
- History of myeloid leukemia, myelodysplastic syndrome, or accompanying sickle cell disease;
- Symptomatic CNS metastases and/or leptomeningeal diseases that require immediate radiotherapy or steroid treatment;
- Have undergone surgery or radiation therapy within 4 weeks prior to the administration of the first dose of the study drug;
- Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 6 months; (4) Patients with clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;
- History of interstitial lung disease, slow progressive dyspnea and dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary allergic pneumonia, or multiple allergic or peripheral arterial diseases (such as claudication, Leo Buerger's disease).
- Patients who have received hematopoietic stem cell or bone marrow transplantation in the past;
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- Patients who need to receive radiation therapy at the same time;
- Those who are known to have a history of allergies to the components of this drug regimen;
- Pregnant or lactating women;
- The researcher believes that the patient is not suitable to participate in any other circumstances of 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, MD, 0592 2137611, wujingxun@xmu.edu.cn
About this study
Official title: A Prospective, Single-arm Phase II Trial of Trilaciclib Administered Prior to Sacituzumab Tirumotecan in Patients With EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors（PROTECT-2）
This study is a prospective, single arm phase II clinical trial aimed at patients with advanced non-small cell lung cancer resistant to EGFR-TKI. The aim is to evaluate the efficacy and safety of trilaciclib in bone marrow protection before monotherapy with sacituzumab tirumotecan.
Patients with advanced non-small cell lung cancer resistant to EGFR-TKI, after signing informed consent, will be screened for eligible subjects who meet the inclusion criteria. Prior to receiving treatment with sacituzumab tirumotecan, they will be treated with trilaciclib until disease progression or intolerable toxicity occurs.
Read more
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 should 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. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest).
After the screening period and one cycle of treatment, subjects may choose to undergo whole-body PET/CT imaging for exploratory analysis.
- Being tested
- Trilaciclib and Sacituzumab Tirumotecan
- 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 and Sacituzumab TirumotecanDrug
Trilaciclib: 240 mg/m2 as a 30-min iv. infusion, completed ≤4h prior to sacituzumab tirumotecan.
Sacituzumab Tirumotecan: 5 mg/kg on days 1 \& 15 of a 28 day cycle via intravenous (IV) infusion until progressive disease or discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib and Sacituzumab Tirumotecan | Experimental | Trilaciclib and Sacituzumab Tirumotecan Receives: Drug: Trilaciclib and Sacituzumab Tirumotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥ 3 neutropenia during sacituzumab tirumotecan treatment
Measured: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Secondary outcomes (11)
Incidence rate of grade 3 or 4 thrombocytopenia
Measured: Time from date of first dose of trilaciclib and sacituzumab tirumotecan 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Incidence rate of grade 3 or 4 anemia during sacituzumab tirumotecan treatment
Measured: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Incidence rate of febrile neutropenia
Measured: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
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 sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Objective response rate (ORR)
Measured: 18 months after the last subject participating in
Disease control rate (DCR)
Measured: 18 months after the last subject participating in
Duration of response (DOR)
Measured: 18 months after the last subject participating in
Progression-free survival (PFS)
Measured: 18 months after the last subject participating in
Overall survival (OS)
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 sacituzumab tirumotecan through 90 days following the last dose of trilaciclib and sacituzumab tirumotecan
Evaluate the relationship between standardized uptake value (SUV) of target lesion at baseline and treatment efficacy of Sacituzumab Tirumotecan.
The changes (%) in lesion SUV values before and after treatment with Sacituzumab Tirumotecan.
Measured: 18 months after the last subject participating in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start8 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- 49 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992739
- Sponsor's protocol ID
- PROTECT-2
- Acronym
- PROTECT-2
- Status last verified
- Mar 2026
- First submitted
- 6 May 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Phase II Trial of Trilaciclib Administered Prior to Sacituzumab Tirumotecan in Patients With EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors（PROTECT-2）
- ClinicalTrials.gov ID
- NCT06992739
- Acronym / sponsor ID
- PROTECT-2 / PROTECT-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 May 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 clinical trial aimed at patients with advanced non-small cell lung cancer resistant to EGFR-TKI. The aim is to evaluate the efficacy and safety of trilaciclib in bone marrow protection before monotherapy with sacituzumab tirumotecan.
Patients with advanced non-small cell lung cancer resistant to EGFR-TKI, after signing informed consent, will be screened for eligible subjects who meet the inclusion criteria. Prior to receiving treatment with sacituzumab tirumotecan, they will be treated with trilaciclib until disease progression or intolerable toxicity occurs.
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 should 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. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest).
After the screening period and one cycle of treatment, subjects may choose to undergo whole-body PET/CT imaging for exploratory analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib and Sacituzumab Tirumotecan | Experimental | Drug: Trilaciclib and Sacituzumab TirumotecanTrilaciclib and Sacituzumab Tirumotecan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age range: 18-75 years old; No gender restrictions;
- ECOG PS score 0-1;
- Expected survival time ≥ 3 months;
- Patients with locally advanced or metastatic EGFR mutant non-small cell lung cancer diagnosed by histological or cytological examination, who have failed third-generation EGFR-TKI treatment and have experienced up to second-line EGFR-TKI treatment failure;
- There must be at least one measurable lesion that meets the RECIST 1.1 criteria;
Key exclusion criteria (10 listed)
- History of myeloid leukemia, myelodysplastic syndrome, or accompanying sickle cell disease;
- Symptomatic CNS metastases and/or leptomeningeal diseases that require immediate radiotherapy or steroid treatment;
- Have undergone surgery or radiation therapy within 4 weeks prior to the administration of the first dose of the study drug;
- Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 6 months; (4) Patients with clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;
- History of interstitial lung disease, slow progressive dyspnea and dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary allergic pneumonia, or multiple allergic or peripheral arterial diseases (such as claudication, Leo Buerger's disease).
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 and Sacituzumab TirumotecanTrilaciclib: 240 mg/m2 as a 30-min iv. infusion, completed ≤4h prior to sacituzumab tirumotecan. Sacituzumab Tirumotecan: 5 mg/kg on days 1 \& 15 of a 28 day cycle via intravenous (IV) infusion until progressive disease or discontinuation. | Drug | Trilaciclib and Sacituzumab Tirumotecan |
Primary outcome
Incidence of grade ≥ 3 neutropenia during sacituzumab tirumotecan treatment
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
11 secondary outcomes
Incidence rate of grade 3 or 4 thrombocytopenia
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Incidence rate of grade 3 or 4 anemia during sacituzumab tirumotecan treatment
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Incidence rate of febrile neutropenia
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Usage rate of symptomatic treatments for myelosuppression
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Objective response rate (ORR)
Time frame: 18 months after the last subject participating in
Disease control rate (DCR)
Time frame: 18 months after the last subject participating in
Duration of response (DOR)
Time frame: 18 months after the last subject participating in
Progression-free survival (PFS)
Time frame: 18 months after the last subject participating in
Overall survival (OS)
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 sacituzumab tirumotecan through 90 days following the last dose of trilaciclib and sacituzumab tirumotecan
Evaluate the relationship between standardized uptake value (SUV) of target lesion at baseline and treatment efficacy of Sacituzumab Tirumotecan.
Time frame: 18 months after the last subject participating in
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 14 Apr 2026.
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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 and Sacituzumab Tirumotecan in people with NSCLC (Advanced Non-small Cell Lung Cancer) and EGFR, 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 14 inclusion and 10 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 14 Apr 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?
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 sacituzumab tirumotecan treatment (time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan). 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 14 Apr 2026.