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Trilaciclib in the treatment of small cell lung cancer chemotherapy or chemotherapy combined with immune regimen bone marrow protection multi-cohort, multi-center, open, exploratory clinical study

Trilaciclib in the treatment of small cell lung cancer chemotherapy or chemotherapy combined with immune regimen bone marrow protection multi-cohort, multi-center, open, exploratory clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086125
Enrollment
Unknown
Registered
2024-06-25
Start date
2024-06-30
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small cell lung cancer

Interventions

test group:Trilaciclib,Pre-chemotherapy

Sponsors

Datong Second People 's Hospital (Cancer Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. signed written informed consent before enrollment; 2. age > 18 years, both men and women; 3. pathological examination confirmed the diagnosis of small cell lung cancer, chemotherapy-based treatment is required; 4. Karnofsky performance status (KPS) = 50 points, expected survival = 3 months, follow-up observation for more than 3 months; 5. blood routine, liver and kidney function, myocardial enzymes and electrocardiogram showed no significant abnormalities. 6. Subjects voluntarily join this study, with good compliance and cooperation in safety and survival follow-up

Exclusion criteria

Exclusion criteria: 1. allergic to biological agents; 2. received any cytotoxic chemotherapy or PD-1/PD-L1 inhibitor treatment = 14 days before the first dose of study drug (if relevant); 3. received any study drug = 30 days or = half-life (whichever is longer) before the first dose of study drug; 4. had poor healing factors such as edema, ischemia, and tension at the anastomotic stoma; 5. complete intestinal obstruction; 6. severe cardiovascular disease; 7. infectious disease; 8. bleeding tendency or coagulation dysfunction; 9. unstable vital signs; 10. cachexia; 11. the investigator believes that it should be excluded from this study, such as the investigator 's judgment that the subject has other factors that may force the study to terminate halfway, such as other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, Or data and sample collection

Design outcomes

Primary

MeasureTime frame
Incidence of severe neutropenia during treatment cycles;Incidence of agranulocytosis with fever during treatment cycles;

Secondary

MeasureTime frame
CD8 +/Treg ratio change;Objective response rate (0RR);Patients' quality of life (QoL);Safty;

Countries

China

Contacts

Public ContactJianfeng Diao

Datong Second People 's Hospital (Cancer Hospital)

xslijing2022@126.com+86 130 1539 2891

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026