Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the myeloprotective effects of trilaciclib in advanced squamous non-small cell lung cancer patients receiving a combination therapy of chemotherapy(carboplatin+paclitaxel) and immune checkpoint inhibitor (tislelizumab), as well as enhancing antitumor efficacy and possible immunological synergies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan University
• Collaborators: Chengdu First people's hospital; Chengdu Second people's hospital; Chengdu Seventh People's Hospital; Enshi Central Hospital; Heilongjiang Provincial Cancer Hospital; Mianyang Central Hospital; Neijiang Hospital of Traditional Chinese Medicine; Shandong Provincial Cancer Hospital; Shanxi Provincial Cancer Hospital
• Treatments: Carboplatin; Paclitaxel; Tislelizumab

Criteria

Inclusion Criteria:

• 1. Age ≥ 18 years old and ≤ 75 years old, male or female;

• 2. Unresectable stage ⅢB and Ⅳ squamous non-small cell lung cancer confirmed by histology or cytology;

• 3. Have not received systemic anti-tumor therapy for advanced tumors in the past;

• 4. There is at least one measurable lesion that meets the RECIST1.1 criteria;

• 5. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases;

• 6. Laboratory tests meet the following criteria: Hemoglobin ≥ 100 G/L (female), 110 G/L (male) Neutrophil count ≥ 2 × 10^9/L Platelet count ≥ 100 × 10^9/L; Creatinine ≤ 15 mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 3 × ULN or ≤ 5 × ULN (for patients with liver metastases); Albumin ≥ 30g/L;

• 7.ECOG PS score 0-1;

• 8. Expected survival time ≥ 3 months;

• 9. Women: All women with potential fertility must have negative serum pregnancy test results during the screening period, and must take reliable contraceptive measures from the signing of informed consent to 3 months after the last administration;

• 10. Understand and sign the informed consent form.

Exclusion Criteria:

• 1. Patients with the following diseases: Known HIV infection, active hepatitis B (defined as HBV DNA positive) and hepatitis C (HCV RNA positive); Interstitial lung disease/lung inflammation; Active, suspected autoimmune disease requiring systemic treatment in the past 2 years;

• 2. Vaccination of live attenuated vaccine within 4 weeks before enrollment, or expected to require vaccination of live attenuated vaccine during the study period;

• 3. Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);

• 4. Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment 5. QTcF > 480 msec at screening and > 500 msec for patients with ventricular pacemakers

• 6. Previous hematopoietic stem cell or bone marrow transplantation

• 7.Hypersensitivity to the study drug or its components;

• 8. Those who are not considered suitable to participate in the study by the investigator.