- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05900921
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yongsheng Wang, professor
- Phone Number: +86 028-85429455
- Email: wangys@scu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 |
IV infusion, d1
IV infusion, d1
IV infusion, d1
IV infusion, d1
|
Active Comparator: 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 |
IV infusion, d1
IV infusion, d1
IV infusion, d1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of grade ≥3 Neutrophil count decreased
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior
to progression or any further therapy.
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Overall Survival (OS)
Time Frame: From randomization until death (up to 24 months)
|
OS is defined as the time until death due to any cause.
|
From randomization until death (up to 24 months)
|
Disease Control Rate (DCR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Progress free survival (PFS)
Time Frame: untill Progressive Disease(PD) or death(up to 24 months)
|
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
|
untill Progressive Disease(PD) or death(up to 24 months)
|
1. incidence of other indicators of Myelosuppression(Grade 4 Neutrophil count decreased, grade 3 or 4 thrombocytopenia, grade 3 or 4 anemia, febrile neutropenia)
Time Frame: 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
|
The criterion for identifying any indicator of myelosuppression was if the preferred term for an adverse event was "event" according CTCAE 5.0 criteria.
Any occurrence of an event during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of events ≥ 1 is observed, No for other scenarios.
Each event with a unique start date during the induction treatment period was defined as a separate event
|
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))
Time Frame: 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
|
Any occurrence of the event during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of the event ≥ 1 is observed, No for other scenarios.
If the patient did not have an event, the value of 0 was assigned to that patient.
Each event with a unique start date during the induction treatment period was defined as a separate event.
|
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
|
Duration of Response (DOR)
Time Frame: Up to approximately 24 months
|
DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death.
|
Up to approximately 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yongsheng Wang, West China Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Carboplatin
- Paclitaxel
- Tislelizumab
Other Study ID Numbers
- SMA-NSCLC-011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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