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

NCT05900921 | Unknown Phase 2

• 1 other identifier: SMA-NSCLC-011
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Squamous Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• incidence of grade ≥3 Neutrophil count decreased

  The " incidence " is defined as the proportion of subjects from randomization to 15 days after the end of first-line chemotherapy treatment in which the events occurred. The occurrence of Grade 3 Neutrophil count decreased was a binary variable. If a patient had at least 1 absolute neutrophil count value \<1 × 10\^9/L during the Induction Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.

  Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator

Secondary Outcomes (7)

• 1. incidence of other indicators of Myelosuppression(Grade 4 Neutrophil count decreased, grade 3 or 4 thrombocytopenia, grade 3 or 4 anemia, febrile neutropenia)

  Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator

• Usage rate of Supportive Intervention(Granulocyte colony-stimulating factor (G-CSF), platelet transfusion, red blood cell transfusion (week 5 and later), erythropoietin (ESA), iron, recombinant human interleukin-11, and/or thrombopoietin (TPO))

  Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator

• Progress free survival (PFS)

  untill Progressive Disease(PD) or death(up to 24 months)

• Overall Survival (OS)

  From randomization until death (up to 24 months)

• Objective Response Rate (ORR)

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (2)

Experimental: Trilaciclib+Chemotherpy+Tislelizumab

EXPERIMENTAL

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

Drug: Trilaciclib; Drug: Carboplatin; Drug: Paclitaxel; Drug: Tislelizumab

Active Comparator: Chemotherpy+Tislelizumab

ACTIVE COMPARATOR

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

Drug: Carboplatin; Drug: Paclitaxel; Drug: Tislelizumab

Interventions

Trilaciclib DRUG

IV infusion, d1

Experimental: Trilaciclib+Chemotherpy+Tislelizumab

Carboplatin DRUG

IV infusion, d1

Active Comparator: Chemotherpy+Tislelizumab; Experimental: Trilaciclib+Chemotherpy+Tislelizumab

Paclitaxel DRUG

IV infusion, d1

Active Comparator: Chemotherpy+Tislelizumab; Experimental: Trilaciclib+Chemotherpy+Tislelizumab

Tislelizumab DRUG

IV infusion, d1

Active Comparator: Chemotherpy+Tislelizumab; Experimental: Trilaciclib+Chemotherpy+Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years old and ≤ 75 years old, male or female;
• \. Unresectable stage ⅢB and Ⅳ squamous non-small cell lung cancer confirmed by histology or cytology;
• \. Have not received systemic anti-tumor therapy for advanced tumors in the past;
• \. There is at least one measurable lesion that meets the RECIST1.1 criteria;
• \. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases;
• \. 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;
• ECOG PS score 0-1;
• \. Expected survival time ≥ 3 months;
• \. 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;
• \. Understand and sign the informed consent form.

You may not qualify if:

• \. 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;
• \. Vaccination of live attenuated vaccine within 4 weeks before enrollment, or expected to require vaccination of live attenuated vaccine during the study period;
• \. Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
• \. 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
• \. Previous hematopoietic stem cell or bone marrow transplantation
• Hypersensitivity to the study drug or its components;
• \. Those who are not considered suitable to participate in the study by the investigator.

Sponsors & Collaborators

• Sichuan University: lead
• Chengdu First People's Hospital: collaborator
• Chengdu Second people's hospital: collaborator
• Chengdu Seventh People's Hospital: collaborator
• Mianyang Central Hospital: collaborator
• Shanxi Provincial Cancer Hospital: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• Heilongjiang Provincial Cancer Hospital: collaborator
• Enshi Central Hospital: collaborator
• Neijiang Hospital of Traditional Chinese Medicine: collaborator

MeSH Terms

Interventions

trilaciclib; Carboplatin; Paclitaxel; tislelizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Yongsheng Wang

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongsheng Wang, professor

CONTACT

+86 028-85429455; wangys@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 13, 2023
• Study Start: July 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 13, 2023

Record last verified: 2023-06