Clinical trial · Interventional
Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer
A Phase II, Randomized, Open-label Trial of Trilaciclib Prior to Chemotherapy Plus Tislelizumab as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Squamous Non-Small-Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| Trilaciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Trilaciclib+Chemotherpy+Tislelizumab
- description
- Participants received 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 trilaciclib with tislelizumab for every 3 weeks
- interventionNames
- Drug: Trilaciclib
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Tislelizumab
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Chemotherpy+Tislelizumab
- description
- Participants received 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 tislelizumab for every 3 weeks until PD
- interventionNames
- Drug: Carboplatin
- Drug: Paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available