MyelosuppressionPhase 3TRACERNCT07881705
A Phase III, Randomized, Double-blind, Multi-center Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer
A Phase 3 study testing Trilaciclib, Etoposide Injection and Carboplatin or Cisplatin Injection in people with Myelosuppression, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The primary goal of this study is to evaluate the myelo-protective effect and safety of Trilaciclib in participants with limited stage small cell lung cancer (LS-SCLC) who are receiving concurrent chemo-radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelosuppression
- What is being tested?
- Trilaciclib, Etoposide Injection and Carboplatin or Cisplatin Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2026to 30 Sep 2027
- Phase
- Phase 3
- 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
- 1. Histologically and/or cytologically confirmed small cell lung cancer (SCLC) with clinical staging confirming limited-stage disease and no evidence of distant metastasis；
- 2. Fit for concurrent chemo-radiotherapy；
- 3. Adverse reactions related to prior anti-tumor surgery have fully recovered；
- 4. Has at least one measurable lesion per RECIST 1.1 that has not been previously irradiated；
- 5. Eastern Cooperative Oncology Group （ECOG）performance status of 0 or 1;
- 6. Has adequate organ and bone marrow function, without receipt of hematopoietic growth factors, blood transfusions, or platelet transfusions within 14 days prior to the first dose of study drug；
Who cannot join
- 1. Extensive-stage small cell lung cancer
- 2. mixed-type small cell lung cancer, and transformed small cell lung cancer；
- 3. Has received prior anti-tumor therapy for small cell lung cancer, including radiotherapy, chemotherapy, or immunotherapy；
- 4. Has known allergy to any study drug or its components, or has any contraindication to any study drug.
- 5. Has any active infections requiring for intravenous treatment within 14 days prior to the first dose of study treatment；
- 6. Has received any live vaccine within 28 days prior to the first dose of study drug.
Show all 16Show fewer
- 7. Has received any major surgeries within 28 days prior to the first dose of study treatment or expects to receive major surgeries during the study;
- 8. History of another active malignancy within the past 5 years, except for localized cancers that have been cured and are considered by the investigator to be at low risk of recurrence, including basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- 9. With a history of active tuberculosis infection within 1 year; trial participants with a history of active tuberculosis may be eligible for enrollment if, in the investigator's judgment, there has been no evidence of active tuberculosis for more than 1 year prior to the first dose.
- 10. Active or chronic hepatitis B or hepatitis C infection;
- 11. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- 12. With clinically significant cardiovascular disease within 6 months prior to the first dose
- 13. History of interstitial lung disease/non-infectious pneumonitis requiring steroid treatment, or current interstitial lung disease/non-infectious pneumonitis requiring steroid treatment;
- 14. Prior allogeneic or autologous hematopoietic stem cell transplantation or history of graft-versus-host disease;
- 15. Pregnant or breastfeeding female trial participants, or female trial participants of childbearing potential. Female participants of childbearing potential may be enrolled if they have a negative blood pregnancy test within 7 days prior to the first dose and agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of study medication or the last radiotherapy, whichever is longer.
- 16. Any other conditions that, in the investigator's opinion, make the participant unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong
About this study
Official title: The Randomized, Double-blind, Multi-center Phase III Clinical Trial of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer Receiving Concurrent Chemo-radiotherapy
The primary goal of this study is to evaluate the myelo-protective effect and safety of Trilaciclib in participants with limited stage small cell lung cancer (LS-SCLC) who are receiving concurrent chemo-radiotherapy.
Researchers will compare Trilaciclib with placebo (a look-alike substance that contains no drug) to see if Trilaciclib works better in protecting the participant's marrow function while receiving concurrent chemo-radiotherapy.
Read the detailed description
The study will enroll approximately 106 participants with LS-CLC. The participants will be randomly assigned in a 1:1 ratio to two groups. One group will receive treatment with Trilaciclib + concurrent chemo-radiotherapy. The other group will receive placebo + concurrent chemo-radiotherapy.
Participants will receive the investigational drug until completion of 4 cycles of Trilaciclib +chemotherapy and concurrent radiotherapy, occurrence of radiographic disease progression, intolerable toxicity, investigator-assessed lack of clinical benefit, voluntary withdrawal from study treatment by the participant or their legally authorized representative, pregnancy, lost to follow-up, death, or study termination, whichever occurs first.
The study process includes screening period, treatment period, end-of-treatment visit, safety follow-up visit, and end-of-study visit.
- Conditions
- Myelosuppression
- Being tested
- Trilaciclib, Trilaciclib Placebo, Etoposide Injection, Carboplatin or Cisplatin Injection, Radiotherapy
- Keywords
- LS-SCLC, small cell lung cancer, Myelosuppression, 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 Cosela
Trilaciclib at 240mg/m^2;
Trilaciclib PlaceboOther
250 mL of 5% dextrose in water or normal saline (0.9% sodium chloride solution)
Etoposide InjectionDrug
Etoposide Injection at dose level of 100 mg/m^2
Carboplatin or Cisplatin InjectionDrug
Use Calvert formula to calculate Carboplatin dosage (AUC=5 mg/mL/min,750 mg at most）; Cisplatin at a dose level of 75 mg/m^2.
RadiotherapyRadiation
30-33 days of totally 60-66 Gy for QD radiation, or 15 days of totally 45 Gy for BID radiation.
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib + concurrent chemo-radiotherapy | Experimental | Drug: Trilaciclib at 240mg/m^2 on Day 1, Day 2, Day 3 of each cycle before chemotherapy, for 4 cycles (21 days as 1 cycle).
Etoposide Injection: 100 mg/m^2, Day 1, Day 2, Day 3 of each cycle, for 4 cycles (21 days as 1 cycle).
Carboplatin or Cisplatin Injection: on Day 1 of each cycle, for 4 cycles (21 days as 1 cycle); use Calvert formula to calculate Carboplatin dosage (AUC=5 mg/mL/min,750 mg at most）; Cisplatin dosage is 75 mg/m^2.
Initiate QD (once daily) or BID (twice a day) radiotherapy during Cycle 2 of radiotherapy. Receives: Drug: Trilaciclib; Drug: Etoposide Injection; Drug: Carboplatin or Cisplatin Injection; Radiation: Radiotherapy |
| Placebo+ concurrent chemo-radiotherapy | Placebo comparator | Drug: Trilaciclib placebo on Day 1, Day 2, Day 3 of each cycle before chemotherapy, for 4 cycles (21 days as 1 cycle).
Etoposide Injection: 100 mg/m^2, Day 1, Day 2, Day 3 of each cycle, for 4 cycles (21 days as 1 cycle).
Carboplatin or Cisplatin Injection: on Day 1 of each cycle, for 4 cycles (21 days as 1 cycle); use Calvert formula to calculate Carboplatin dosage (AUC=5 mg/mL/min,750 mg at most）; Cisplatin dosage is 75 mg/m^2.
Initiate QD (once daily) or BID (twice a day) radiotherapy during Cycle 2 of radiotherapy. Receives: Other: Trilaciclib Placebo; Drug: Etoposide Injection; Drug: Carboplatin or Cisplatin Injection; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of severe neutropenia (DSN) in cycle 1
The time duration of absolute neutrophil count (ANC) decrease meeting Grade 4 per NCI CTCAE 5.0 (i.e., ANC < 0.5 × 10⁹/L).
Measured: During the first cycle (each cycle is 21 days)
The incidence of severe neutropenia (SN)
The incidence of absolute neutrophil count (ANC) decrease meeting Grade 4 per NCI CTCAE 5.0 (i.e., ANC < 0.5 × 10⁹/L).
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Secondary outcomes (12)
Granulocyte colony-stimulating factor (G-CSF) utilization rate
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Incidence of febrile neutropenia
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
The lowest absolute neutrophil count in each cycle
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months]
Incidence of grade ≥3 hemoglobin decrease
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 month
Incidence of red blood cell transfusions (from Week 5 onward)
Measured: From Week 5 until 30 days after the end of study treatment, up to about 3 months
Erythropoiesis-stimulating agent (ESA) utilization rate
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Incidence of grade ≥3 platelet count decrease
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Incidence of platelet transfusions
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months.
Rate of thrombopoiesis-stimulating agent use.
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Incidence of grade 3 and 4 hematologic toxicities
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Changes over time in absolute neutrophil count, platelet count, absolute lymphocyte count, and hemoglobin
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Composite endpoint: Incidence of important hematologic adverse events.
The proportion of patients who experience any of the following: hematologic adverse event that leads to hospitalization or prolongation of hospitalization, dose adjustment of chemotherapy, febrile neutropenia, prolongation of severe neutropenia(SN) (more than 5 days),or red blood cell (RBC) transfusions administered at or after Week 5.
Measured: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start17 Jun 2026
- Primary completion15 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelosuppressionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simcere Zaiming Pharmaceutical Co., Ltd .
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881705
- Sponsor's protocol ID
- SIM0358-303
- Other IDs
- CTR20262087
- Acronym
- TRACER
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized, Double-blind, Multi-center Phase III Clinical Trial of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer Receiving Concurrent Chemo-radiotherapy
- ClinicalTrials.gov ID
- NCT07881705
- Acronym / sponsor ID
- TRACER / SIM0358-303
- Conditions
- Myelosuppression
- Keywords
- LS-SCLC, small cell lung cancer, Myelosuppression, Trilaciclib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Simcere Zaiming Pharmaceutical Co., Ltd .
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Oct 2026 (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 primary goal of this study is to evaluate the myelo-protective effect and safety of Trilaciclib in participants with limited stage small cell lung cancer (LS-SCLC) who are receiving concurrent chemo-radiotherapy.
Researchers will compare Trilaciclib with placebo (a look-alike substance that contains no drug) to see if Trilaciclib works better in protecting the participant's marrow function while receiving concurrent chemo-radiotherapy.
Detailed description
The study will enroll approximately 106 participants with LS-CLC. The participants will be randomly assigned in a 1:1 ratio to two groups. One group will receive treatment with Trilaciclib + concurrent chemo-radiotherapy. The other group will receive placebo + concurrent chemo-radiotherapy.
Participants will receive the investigational drug until completion of 4 cycles of Trilaciclib +chemotherapy and concurrent radiotherapy, occurrence of radiographic disease progression, intolerable toxicity, investigator-assessed lack of clinical benefit, voluntary withdrawal from study treatment by the participant or their legally authorized representative, pregnancy, lost to follow-up, death, or study termination, whichever occurs first.
The study process includes screening period, treatment period, end-of-treatment visit, safety follow-up visit, and end-of-study visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib + concurrent chemo-radiotherapy | Experimental | Drug: Trilaciclib, Drug: Etoposide Injection, Drug: Carboplatin or Cisplatin Injection, Radiation: RadiotherapyDrug: Trilaciclib at 240mg/m^2 on Day 1, Day 2, Day 3 of each cycle before chemotherapy, for 4 cycles (21 days as 1 cycle). Etoposide Injection: 100 mg/m^2, Day 1, Day 2, Day 3 of each cycle, for 4 cycles (21 days as 1 cycle). Carboplatin or Cisplatin Injection: on Day 1 of each cycle, for 4 cycles (21 days as 1 cycle); use Calvert formula to calculate Carboplatin dosage (AUC=5 mg/mL/min,750 mg at most）; Cisplatin dosage is 75 mg/m^2. Initiate QD (once daily) or BID (twice a day) radiotherapy during Cycle 2 of radiotherapy. |
| Placebo+ concurrent chemo-radiotherapy | Placebo comparator | Other: Trilaciclib Placebo, Drug: Etoposide Injection, Drug: Carboplatin or Cisplatin Injection, Radiation: RadiotherapyDrug: Trilaciclib placebo on Day 1, Day 2, Day 3 of each cycle before chemotherapy, for 4 cycles (21 days as 1 cycle). Etoposide Injection: 100 mg/m^2, Day 1, Day 2, Day 3 of each cycle, for 4 cycles (21 days as 1 cycle). Carboplatin or Cisplatin Injection: on Day 1 of each cycle, for 4 cycles (21 days as 1 cycle); use Calvert formula to calculate Carboplatin dosage (AUC=5 mg/mL/min,750 mg at most）; Cisplatin dosage is 75 mg/m^2. Initiate QD (once daily) or BID (twice a day) radiotherapy during Cycle 2 of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Histologically and/or cytologically confirmed small cell lung cancer (SCLC) with clinical staging confirming limited-stage disease and no evidence of distant metastasis；
- 2. Fit for concurrent chemo-radiotherapy；
- 3. Adverse reactions related to prior anti-tumor surgery have fully recovered；
- 4. Has at least one measurable lesion per RECIST 1.1 that has not been previously irradiated；
- 5. Eastern Cooperative Oncology Group （ECOG）performance status of 0 or 1;
Key exclusion criteria (16 listed)
- 1. Extensive-stage small cell lung cancer
- 2. mixed-type small cell lung cancer, and transformed small cell lung cancer；
- 3. Has received prior anti-tumor therapy for small cell lung cancer, including radiotherapy, chemotherapy, or immunotherapy；
- 4. Has known allergy to any study drug or its components, or has any contraindication to any study drug.
- 5. Has any active infections requiring for intravenous treatment within 14 days prior to the first dose of study 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: CoselaTrilaciclib at 240mg/m^2; | Drug | Trilaciclib + concurrent chemo-radiotherapy |
| Trilaciclib Placebo250 mL of 5% dextrose in water or normal saline (0.9% sodium chloride solution) | Other | Placebo+ concurrent chemo-radiotherapy |
| Etoposide InjectionEtoposide Injection at dose level of 100 mg/m^2 | Drug | Placebo+ concurrent chemo-radiotherapy, Trilaciclib + concurrent chemo-radiotherapy |
| Carboplatin or Cisplatin InjectionUse Calvert formula to calculate Carboplatin dosage (AUC=5 mg/mL/min,750 mg at most）; Cisplatin at a dose level of 75 mg/m^2. | Drug | Placebo+ concurrent chemo-radiotherapy, Trilaciclib + concurrent chemo-radiotherapy |
| Radiotherapy30-33 days of totally 60-66 Gy for QD radiation, or 15 days of totally 45 Gy for BID radiation. | Radiation | Placebo+ concurrent chemo-radiotherapy, Trilaciclib + concurrent chemo-radiotherapy |
Primary outcome
The duration of severe neutropenia (DSN) in cycle 1
Time frame: During the first cycle (each cycle is 21 days)
The time duration of absolute neutrophil count (ANC) decrease meeting Grade 4 per NCI CTCAE 5.0 (i.e., ANC < 0.5 × 10⁹/L).
The incidence of severe neutropenia (SN)
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
The incidence of absolute neutrophil count (ANC) decrease meeting Grade 4 per NCI CTCAE 5.0 (i.e., ANC < 0.5 × 10⁹/L).
12 secondary outcomes
Granulocyte colony-stimulating factor (G-CSF) utilization rate
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Incidence of febrile neutropenia
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
The lowest absolute neutrophil count in each cycle
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months]
Incidence of grade ≥3 hemoglobin decrease
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 month
Incidence of red blood cell transfusions (from Week 5 onward)
Time frame: From Week 5 until 30 days after the end of study treatment, up to about 3 months
Erythropoiesis-stimulating agent (ESA) utilization rate
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Incidence of grade ≥3 platelet count decrease
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Incidence of platelet transfusions
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months.
Rate of thrombopoiesis-stimulating agent use.
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Incidence of grade 3 and 4 hematologic toxicities
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Changes over time in absolute neutrophil count, platelet count, absolute lymphocyte count, and hemoglobin
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
Composite endpoint: Incidence of important hematologic adverse events.
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
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 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 3 study testing Trilaciclib, Etoposide Injection and Carboplatin or Cisplatin Injection in people with Myelosuppression, 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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 duration of severe neutropenia (DSN) in cycle 1 (time frame: During the first cycle (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 19 Oct 2026.