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Trial · NCT07881705

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

NCT07881705, Phase 3, Active not recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 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. Trials, record NCT07881705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07881705

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
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
NCT number
NCT07881705
Status
Active not recruiting
Phases
Phase 3
Enrollment
106 participants, actual
Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions
Myelosuppression
Interventions
Trilaciclib, Trilaciclib Placebo, Etoposide Injection, Carboplatin or Cisplatin Injection, Radiotherapy
First posted
2026-10-19
Last updated
2026-10-19

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe duration of severe neutropenia (DSN) in cycle 1During 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).
PrimaryThe incidence of severe neutropenia (SN)From the time of first dosing until 30 days after the end of study treatment, up to about 3.5 monthsThe incidence of absolute neutrophil count (ANC) decrease meeting Grade 4 per NCI CTCAE 5.0 (i.e., ANC \< 0.5 × 10⁹/L).
SecondaryGranulocyte colony-stimulating factor (G-CSF) utilization rateFrom the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
SecondaryIncidence of febrile neutropeniaFrom the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
SecondaryThe lowest absolute neutrophil count in each cycleFrom the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months]
SecondaryIncidence of grade ≥3 hemoglobin decreaseFrom the time of first dosing until 30 days after the end of study treatment, up to about 3.5 month
SecondaryIncidence of red blood cell transfusions (from Week 5 onward)From Week 5 until 30 days after the end of study treatment, up to about 3 months
SecondaryErythropoiesis-stimulating agent (ESA) utilization rateFrom the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
SecondaryIncidence of grade ≥3 platelet count decreaseFrom the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months
SecondaryIncidence of platelet transfusionsFrom the time of first dosing until 30 days after the end of study treatment, up to about 3.5 months.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07881705

GET https://conductscience.org/api/trials/v1/NCT07881705/registered