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Trial Title:
Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer
NCT ID:
NCT05900921
Condition:
Advanced Squamous Non-Small-Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trilaciclib
Description:
IV infusion, d1
Arm group label:
Experimental: Trilaciclib+Chemotherpy+Tislelizumab
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
IV infusion, d1
Arm group label:
Active Comparator: Chemotherpy+Tislelizumab
Arm group label:
Experimental: Trilaciclib+Chemotherpy+Tislelizumab
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
IV infusion, d1
Arm group label:
Active Comparator: Chemotherpy+Tislelizumab
Arm group label:
Experimental: Trilaciclib+Chemotherpy+Tislelizumab
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
IV infusion, d1
Arm group label:
Active Comparator: Chemotherpy+Tislelizumab
Arm group label:
Experimental: Trilaciclib+Chemotherpy+Tislelizumab
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.
Detailed description:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Collaborator:
Agency:
Chengdu First people's hospital
Agency class:
Other
Collaborator:
Agency:
Chengdu Second people's hospital
Agency class:
Other
Collaborator:
Agency:
Chengdu Seventh People's Hospital
Agency class:
Other
Collaborator:
Agency:
Mianyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Shanxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Heilongjiang Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Enshi Central Hospital
Agency class:
Other
Collaborator:
Agency:
Neijiang Hospital of Traditional Chinese Medicine
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05900921
