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

NCT ID: NCT05900921

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Advanced Squamous Non-Small-Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Trilaciclib+Chemotherpy+Tislelizumab

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

Group Type: EXPERIMENTAL

Trilaciclib

Intervention Type: DRUG

IV infusion, d1

Carboplatin

Intervention Type: DRUG

IV infusion, d1

Paclitaxel

Intervention Type: DRUG

IV infusion, d1

Tislelizumab

Intervention Type: DRUG

IV infusion, d1

Active Comparator: Chemotherpy+Tislelizumab

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

Group Type: ACTIVE_COMPARATOR

Carboplatin

Intervention Type: DRUG

IV infusion, d1

Paclitaxel

Intervention Type: DRUG

IV infusion, d1

Tislelizumab

Intervention Type: DRUG

IV infusion, d1

Interventions

Trilaciclib

IV infusion, d1

Intervention Type: DRUG

Carboplatin

IV infusion, d1

Intervention Type: DRUG

Paclitaxel

IV infusion, d1

Intervention Type: DRUG

Tislelizumab

IV infusion, d1

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu First People's Hospital

OTHER

Sponsor Role: collaborator

Chengdu Second people's hospital

UNKNOWN

Sponsor Role: collaborator

Chengdu Seventh People's Hospital

UNKNOWN

Sponsor Role: collaborator

Mianyang Central Hospital

OTHER

Sponsor Role: collaborator

Shaanxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: collaborator

Heilongjiang Provincial Cancer Hospital

UNKNOWN

Sponsor Role: collaborator

Enshi Central Hospital

UNKNOWN

Sponsor Role: collaborator

Neijiang Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Yongsheng Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongsheng Wang

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Central Contacts

Yongsheng Wang, professor

Role: CONTACT

wangys@scu.edu.cn

+86 028-85429455

Other Identifiers

SMA-NSCLC-011

Identifier Type: -

Identifier Source: org_study_id