Active, not recruitingNCT07881705TRACERUpdated Oct 19, 2026

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 interventional study of Trilaciclib and Trilaciclib Placebo in Myelosuppression, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. (part of Simcere Pharmaceutical Group Limited) · Phase 3, Interventional, and Prevention

From the registry’s dates

Registered 3 months after the study started (first participant enrolled Jun 2026, registered Oct 2026).

Updated Oct 19, 2026Newly registeredGo to Updates ↓

Phase: Phase 3
Study type: Interventional
Enrollment: 106
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

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 studied

Myelosuppression

Browse trials for

Small Cell Lung Carcinoma 1,234

Keywords

LS-SCLC
small cell lung cancer
Myelosuppression
Trilaciclib

In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's enrollment of 106 is above the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 76 studies on the registry; 13 are open to participants now.

Browse Jiangsu Simcere Pharmaceutical Co., Ltd. studies →All Simcere Pharmaceutical Group Limited studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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；

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 106 participants (actual)

Study arms

Experimental
Trilaciclib + concurrent chemo-radiotherapy
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.
Drug: Trilaciclib · Drug: Etoposide Injection · Drug: Carboplatin or Cisplatin Injection · Radiation: Radiotherapy
Placebo comparator
Placebo+ concurrent chemo-radiotherapy
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.
Other: Trilaciclib Placebo · Drug: Etoposide Injection · Drug: Carboplatin or Cisplatin Injection · Radiation: Radiotherapy

Interventions

DrugTrilaciclib
Trilaciclib at 240mg/m\^2;
Also known as: Cosela
OtherTrilaciclib Placebo
250 mL of 5% dextrose in water or normal saline (0.9% sodium chloride solution)
DrugEtoposide Injection
Etoposide Injection at dose level of 100 mg/m\^2
DrugCarboplatin or Cisplatin Injection
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.
RadiationRadiotherapy
30-33 days of totally 60-66 Gy for QD radiation, or 15 days of totally 45 Gy for BID radiation.

What researchers measure

Primary outcomes

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).
Time frame: 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).
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months

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.
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.
Time frame: From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months

Study locations

1 site

Shandong Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.

Of 56 industry-sponsored phase 3 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 44. This study's planned 12 months is below that.

Counting every sponsor, half of 71 studies reached it within 39 months; a quarter within 31 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 12, 2026
First posted: Oct 19, 2026
StartActual: Jun 17, 2026
Primary completionEst.: Jul 15, 2027
CompletionEst.: Sep 30, 2027
Last update: Oct 19, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 19, 2026

Show all 1 update

Oct 19, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07881705
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators: Simcere Zaiming Pharmaceutical Co., Ltd .
Responsible party: Sponsor
First posted: Oct 19, 2026
Start date: Jun 17, 2026
Primary completion: Jul 15, 2027 (estimated)
Completion: Sep 30, 2027 (estimated)
Last update: Oct 19, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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