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Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT06992739 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-14

No results posted yet for this study

Summary

This study is a prospective, single arm phase II clinical trial aimed at patients with advanced non-small cell lung cancer resistant to EGFR-TKI. The aim is to evaluate the efficacy and safety of trilaciclib in bone marrow protection before monotherapy with sacituzumab tirumotecan.

Patients with advanced non-small cell lung cancer resistant to EGFR-TKI, after signing informed consent, will be screened for eligible subjects who meet the inclusion criteria. Prior to receiving treatment with sacituzumab tirumotecan, they will be treated with trilaciclib until disease progression or intolerable toxicity occurs.

Record the dynamic changes of whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Transfusion of blood products and supplementation of hematopoietic raw materials. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination should be conducted within 21 days prior to the first administration, and tumor imaging evaluation shall be conducted every 6 weeks (± 7 days) from the first study drug administration, or the frequency of imaging evaluation may be increased when there are clinical indications. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest).

After the screening period and one cycle of treatment, subjects may choose to undergo whole-body PET/CT imaging for exploratory analysis.

Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)
  • EGFR
  • Myelosuppression

Interventions

DRUG

Trilaciclib and Sacituzumab Tirumotecan

Trilaciclib: 240 mg/m2 as a 30-min iv. infusion, completed ≤4h prior to sacituzumab tirumotecan. Sacituzumab Tirumotecan: 5 mg/kg on days 1 \& 15 of a 28 day cycle via intravenous (IV) infusion until progressive disease or discontinuation.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06992739 on ClinicalTrials.gov