Non-Small Cell Lung CancerPhase 2NCT06297811
Myeloprotection With Trilaciclib in Pan-cancer Population
A Phase 2 study testing Trilaciclib Injection, Paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer and Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are: effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy does trilaciclib… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Breast Cancer, Endometrial Cancer
- What is being tested?
- Trilaciclib Injection, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
- Histologically or cytologically confirmed advanced or recurrent solid malignant tumors, including:
- Unresectable stage III/IV non-small cell lung cancer (NSCLC);
- Recurrent or metastatic breast cancer (BC);
- Newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IC-IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer without further surgical planning before disease progression; or recurrent platinum-sensitive ovarian cancer (OC);
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- FIGO stage III-IV or recurrent endometrial cancer (EC), including endometrioid carcinoma and serous or clear cell carcinoma;
- FIGO stage IVB (including persistent) or recurrent cervical cancer (CC) (≤ 1 prior platinum-based therapy) not amenable to radical surgery or radiotherapy;
- Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (including primary lesions located in the larynx, oropharynx, hypopharynx, oral cavity, undifferentiated or poorly differentiated nasopharyngeal carcinoma, and salivary gland carcinoma), which is not suitable for further surgery or radiotherapy.
- At least one measurable lesion according to RECIST version 1.1;
- Received up to one prior systemic chemotherapy and no prior paclitaxel plus carboplatin chemotherapy;
- Adequate organ function meeting the following criteria: (1) adequate bone marrow function: Hb ≥ 100 g/L (no ESA or blood transfusion within 14 days before the first dose); ANC ≥ 2 × 10^9/L (no G-CSF within 14 days before the first dose); platelet count ≥ 100 × 10^9/L (no rhTPO, rhIL-11 or platelet transfusion within 14 days before the first dose); (2) adequate liver and kidney function: alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula); (3) adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 55%;
- Life expectancy ≥ 3 months;
- Females of childbearing potential agree to practice reliable contraception during the clinical trial and have a negative serum or urine pregnancy test within 7 days prior to dosing;
- Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Who cannot join
- History of myeloid leukemia, myelodysplastic syndrome, or concomitant sickle cell disease;
- Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiation or steroid therapy;
- Received surgery or radiotherapy within 4 weeks prior to the first dose of study drug;
- Receipt of any investigational drug ≤ 30 days or ≤ 5 half-lives (whichever is longer) prior to the first dose of study drug;
- Platinum-resistant OC (refractory to 1 line of platinum-based chemotherapy or recurrent platinum-based chemotherapy within 6 months prior to the first dose of study drug);
- Requires concurrent radiotherapy;
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- Known history of hypersensitivity to the drug components of this protocol;
- Pregnant or lactating women;
- Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation 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
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official title: Efficacy and Safety of Trilaciclib in Myeloprotection During Chemotherapy for Advanced/Recurrent Malignant Solid Tumors - A Phase II Study
The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are:
- effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy
- does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type
Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy.
- Conditions
- Non-Small Cell Lung Cancer, Breast Cancer, Endometrial Cancer, Cervical Cancer, Head And Neck Squamous Cell Carcinomas
- Being tested
- Trilaciclib Injection, Paclitaxel, Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trilaciclib InjectionDrug
Experimental: trilaciclib group Intervention: Drug: Trilaciclib Injection [Cosela] 240 mg/m^2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day
PaclitaxelDrug
Drug: Paclitaxel 175 mg/m^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.
CarboplatinDrug
area under curve(AUC) 5~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib group | Experimental | Not described Receives: Drug: Trilaciclib Injection; Drug: Paclitaxel; Drug: Carboplatin |
| Control group | Active comparator | Not described Receives: Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of grade 3/4 neutropenia within 6 cycles
Percentage of patients with at least one absolute neutrophil count (ANC) < 1.0 × 10 ^ 9/L in total number of patients included in the analysis set.
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2027 (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 Sun Yat-sen 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297811
- Sponsor's protocol ID
- SMA PT 001
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Trilaciclib in Myeloprotection During Chemotherapy for Advanced/Recurrent Malignant Solid Tumors - A Phase II Study
- ClinicalTrials.gov ID
- NCT06297811
- Acronym / sponsor ID
- SMA PT 001
- Conditions
- Non-Small Cell Lung Cancer, Breast Cancer, Endometrial Cancer, Cervical Cancer, Head And Neck Squamous Cell Carcinomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Mar 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.
The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are:
- effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy
- does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type
Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib group | Experimental | Drug: Trilaciclib Injection, Drug: Paclitaxel, Drug: Carboplatin |
| Control group | Active comparator | Drug: Paclitaxel, Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
- Histologically or cytologically confirmed advanced or recurrent solid malignant tumors, including:
- At least one measurable lesion according to RECIST version 1.1;
- Received up to one prior systemic chemotherapy and no prior paclitaxel plus carboplatin chemotherapy;
Key exclusion criteria (9 listed)
- History of myeloid leukemia, myelodysplastic syndrome, or concomitant sickle cell disease;
- Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiation or steroid therapy;
- Received surgery or radiotherapy within 4 weeks prior to the first dose of study drug;
- Receipt of any investigational drug ≤ 30 days or ≤ 5 half-lives (whichever is longer) prior to the first dose of study drug;
- Platinum-resistant OC (refractory to 1 line of platinum-based chemotherapy or recurrent platinum-based chemotherapy within 6 months prior to the first dose of study drug);
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 InjectionExperimental: trilaciclib group Intervention: Drug: Trilaciclib Injection [Cosela] 240 mg/m^2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day | Drug | Trilaciclib group |
| PaclitaxelDrug: Paclitaxel 175 mg/m^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles. | Drug | Control group, Trilaciclib group |
| Carboplatinarea under curve(AUC) 5~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles. | Drug | Control group, Trilaciclib group |
Primary outcome
Occurrence of grade 3/4 neutropenia within 6 cycles
Time frame: Up to 18 weeks
Percentage of patients with at least one absolute neutrophil count (ANC) < 1.0 × 10 ^ 9/L in total number of patients included in the analysis set.
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 7 Mar 2024.
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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 Injection, Paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer and Breast Cancer, run by Sun Yat-sen 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 15 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: opening soon, as of the sponsor's last update on 7 Mar 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?
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?
Contact Ruihua Xu, PhD (+86-13922206676, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of grade 3/4 neutropenia within 6 cycles (time frame: Up to 18 weeks). 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 7 Mar 2024.