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| Name | Class |
|---|---|
| Chengdu First People's Hospital | OTHER |
| Chengdu Second people's hospital | UNKNOWN |
| Chengdu Seventh People's Hospital | UNKNOWN |
| Mianyang Central Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trilaciclib | Drug | IV infusion, d1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 1. incidence of other indicators of Myelosuppression(Grade 4 Neutrophil count decreased, grade 3 or 4 thrombocytopenia, grade 3 or 4 anemia, febrile neutropenia) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsheng Wang, professor | Contact | +86 028-85429455 | wangys@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongsheng Wang | West China Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C000708352 | trilaciclib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
| Heilongjiang Provicial Hospital | OTHER |
| Enshi Central Hospital | UNKNOWN |
| Neijiang Hospital of Traditional Chinese Medicine | UNKNOWN |
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| Carboplatin |
| Drug |
IV infusion, d1 |
|
| Paclitaxel | Drug | IV infusion, d1 |
|
| Tislelizumab | Drug | IV infusion, d1 |
|
| 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)) | 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 |
| Progress free survival (PFS) | 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) |
| Overall Survival (OS) | OS is defined as the time until death due to any cause. | From randomization until death (up to 24 months) |
| Objective Response Rate (ORR) | 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) |
| Disease Control Rate (DCR) | 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) |
| Duration of Response (DOR) | 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 |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |