NCT06992739

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

A Prospective, Single-arm Phase II Trial of Trilaciclib Administered Prior to Sacituzumab Tirumotecan in Patients With EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors（PROTECT-2）

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-12-08
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2025-05-28
• Last updated: 2026-04-14

Locations

1 site across 1 country: China