trilaciclib prior to chemotherapy plus tislelizumab as 1l treatment for advanced squamous non-small-cell lung cancer

Conditions: Advanced Squamous Non-Small-Cell Lung Cancer

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.

this is a phase 2 clinical trial that is randomized, controlled, multicenter, and prospective in design. a total of 132 patients with advanced, untreated squamous non-small cell lung cancer will be randomly assigned 1:1 to receive or not receive trilaciclib (240mg/m2) in combination with paclitaxel (175mg/m2), cisplatin (auc=5), and tislelizumab (200mg) treatment, every 3 weeks for up to 4-6 cycles (induction). following induction, patients will receive or not receive trilaciclib with tislelizumab for every 3 weeks until pd, intolerable toxicity, withdrawal, or death. if subsequent chemotherapy is indicated for patients after first-line progression, trilaciclib will be provided to observe the myeloprotective effect in second-line treatment. the study is expected to commence recruitment in mainland china in about may 2023. it is expected that the trial will end in december 2025.

Eligibility 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.