Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

Trilaciclib:240mg/m2 IV d1,within 4h before chemotherapy; Envafolimab:300mg SC d1,Q3W; Docetaxel:75mg/m2 IV d1, Q3W

Envafolimab:300mg SC d1,Q3W; Docetaxel:75mg/m2 IV d1, Q3W

This is a multi-arm, randomized, controlled, multicenter, Phase II clinical study. Participants randomly assigned at a 1:1:1 ratio to three groups, and will be treated until disease progression, intolerance, withdrawal of consent or completion determined by the investigator.

Trilaciclib+Envafolimab+Docetaxel

Envafolimab+Docetaxel

Wang Jialei, doctor

To evaluate the efficacy and safety of Envafolimab Plus Docetaxel in combination with or without Trilaciclib versus docetaxel IN patients with advanced non-small cell lung cancer previously treated with a PD-1 inhibitor combined with chemotherapy

Trilaciclib indication: Trilaciclib, a CDK4/6 inhibitor, was used before chemotherapy to reduce the incidence of bone marrow suppression, approved by FDA and NMPA for small cell lung cancer in 2021 and in 2022.

Envafolimab indication: Envafolimab, a PD-L1 inhibitor, was used for unresectable or metastatic, MSI-H or dMMR, Adult patients with advanced solid tumors, approved by NMPA in 2021.

Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC

The Study of Envafolimab Plus Docetaxel in Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC Previously Treated With a PD-1 Inhibitor Combined With Chemotherapy

Progression-free survival (PFS per RECIST 1.1) is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.

The proportion of subjects with complete response (CR) and partial response (PR) in total subjects.

The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects.

DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

Defined as the time from randomization to all-cause death.

Quality of life was assessed using the EQ-5D-5L scale

TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration

Fudan University

professor of medicine

Blood and Lymph Conditions

Rare Diseases

Anemia

Small Cell Lung Carcinoma

Neutropenia

Small Cell Lung Cancer

Granulocytopenia

Topotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.

Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²)

Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.

Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²).

Participants will receive intravenous trilaciclib infusion

Trilaciclib

Participants will receive intravenous placebo infusion

Placebo

Participants will receive intravenous topotecan infusion

G1 Therapeutics

Markus Rauter, MD

Robab Breyer Kohansal, MD

Marie Kathrin Breyer, MD

Frederic Forget, MD

Marie Lecocq, MD

Frédérique Bustin, MD

Nataliya Chilingirova, MD

Ivan Tonev, MD

Vladimir Kanarev, MD

Velko Minchev, MD

Tamta Makharadze, MD

Khatuna Bibichadze, MD

Vladimer Kuchava, MD

Tamar Melkadze, MD

Tsira Kortua, MD

David Giorgadze, MD

Miranda Gogishvili, MD

Bernhard Heinrich, MD

Wolfgang Gleiber, MD

Wolfgang Schuette, MD

Claas Wesseler, MD

Sabine Bohnet, MD

Flora Zagouri, MD

Konstantinos Syrigos, MD

Eleni Linardou, MD

Dimitrios Bafaloukos, MD

Ioannis Boukovinas, MD

Elena Fountzila, MD

Andrea Fulop, MD

Ibolya Laczo, MD

Zsolt Horvath, MD

Zsolt Papai-Szekely

Renata Bocskei, MD

Gabriella Galffy, MD

Sandor Tehenes, MD

Maria Pawlowicz, MD

Michal Parkitny, MD

Lukasz Matczak, MD

Jaroslaw Kolb-Sielecki, MD

Aleksandra Szczesna, MD

Justyna Kaj, MD

Isidoro Carlos Barneto Aranda, MD

Carlos Rivas Corredor, MD

Emilio Esteban Gonzalez, MD

Juana Oramas, MD

Jose Fuentes Pradera, MD

Ignacio Gil Bazo, MD

Ahmet Sezer, MD

Mehmet Ali Sendur, MD

Saadettin Kilickap, MD

Irfan Cicin, MD

Mahmut Gumus, MD

Mustafa Ozguroglu, MD

Osman Kostek, MD

Ahmet Bilici, MD

Cagatay Arslan, MD

Hakan Harputluoglu, MD

This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.

The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.

Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.

Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy

To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan

To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan

To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan

To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan

Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1

Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs

Occurrence of CTCAE Grade 3 or 4 decreased hemoglobin laboratory values and ESA administration

RBC transfusions on or after Week 5 (occurrence)

RBC transfusions on or after Week 5 (number of transfusions)

Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (occurrence)

Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (number of transfusions)

Occurrence of hospitalizations due to chemotherapy-induced myelosuppression

Number of hospitalizations due to chemotherapy-induced myelosuppression

To assess the effects of trilaciclib on chemotherapy dosing (delays) compared with placebo when administered prior to topotecan.

To assess the effects of trilaciclib on chemotherapy dosing (reductions) compared with placebo when administered prior to topotecan.

To assess the effects of trilaciclib administered prior to topotecan compared with placebo administered prior to topotecan on occurrence and severity of adverse events by CTCAE, study treatment discontinuation due to adverse events, and trilaciclib adverse events of special interest

G1 Therapeutics, Inc.

Paclitaxel

Carboplatin

Tislelizumab

Albumin-Bound Paclitaxel

Cisplatin

Antineoplastic Agents, Immunological

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

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

Yongsheng Wang, professor

Yongsheng Wang

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.

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

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.

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

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.

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.

OS is defined as the time until death due to any cause.

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.

Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

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.

Chengdu First people's hospital

Chengdu Second people's hospital

Chengdu Seventh People's Hospital

Mianyang Central Hospital

Shanxi Provincial Cancer Hospital

Shandong Provincial Cancer Hospital

Heilongjiang Provincial Cancer Hospital

Enshi Central Hospital

Neijiang Hospital of Traditional Chinese Medicine

Sichuan University

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Pharmaceutical Solutions

Sacituzumab govitecan

Immunoconjugates

Immunologic Factors

During the Treatment Phase patients will receive trilaciclib + sacituzumab govitecan-hziy on days 1 \& 8 of a 21 day cycle. Trilaciclib is administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion to be completed within 4 hours prior to the start of sacituzumab govitecan-hziy.

Single-use, sterile powder to be reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or dextrose 5% in water (D5W)

10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline

Sacituzumab Govitecan-hziy

Clinical Conduct

This is a Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.

The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of the first dose of study treatment and completes at the Safety Follow-up Visit. Trilaciclib and sacituzumab govitecan-hziy will be administered intravenously (IV) in 21-day cycles. Study drug administration will continue until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurs first. The first Survival Follow-up assessment should occur approximately 3 months after the Safety Follow-Up Visit and will continue every 3 months until the end of the study (or death).

Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting

Progression free survival defined as time from the date of first dose of study drug to radiographic disease progression using RECIST v1.1 or death due to any cause, whichever occurs first; for patients without disease progression or death, PFS will be calculated per censoring rules.

Objective response rate defined as the percentage of patients with best overall response of confirmed complete response or confirmed partial response per RECIST v1.1

Clinical benefit rate defined as the percentage of patients with a best overall response of confirmed complete response, confirmed partial response, or stable disease lasting 24 weeks or longer since the first date of study drug administration per RECIST v1.1

Overall survival defined as time from the date of first dose of study drug to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases)

Occurrence of severe neutropenia (in Cycles 1/2 and the overall on study), occurrence of febrile neutropenia AEs , and occurrence of G-CSF administration

Occurrence of Grade 3/4 decrease of hemoglobin, occurrence and number of RBC transfusions on/after Week 5, and occurrence of ESA administration

Occurrence of Grade 3/4 decrease of platelets and occurrence and number of platelet transfusions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC	NCT05910034	Advanced Non-Sm...	Trilaciclib+Env... Envafolimab+Doc... Docetaxel	18 Years -	Fudan University
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan	NCT05874401	Extensive-stage...	Trilaciclib Placebo Topotecan	18 Years -	G1 Therapeutics, Inc.
Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer	NCT05900921	Advanced Squamo...	Trilaciclib Carboplatin Paclitaxel Tislelizumab	18 Years - 75 Years	Sichuan University
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan	NCT05874401	Extensive-stage...	Trilaciclib Placebo Topotecan	18 Years -	G1 Therapeutics, Inc.
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer	NCT05113966	Triple Negative...	Trilaciclib Sacituzumab Gov...	18 Years -	G1 Therapeutics, Inc.
Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy	NCT05978648	Breast Neoplasm...	Trilaciclib Epirubicin Cyclophosphamid... Paclitaxel Docetaxel Carboplatin Trastuzumab Pertuzumab	18 Years -	Sun Yat-sen University
Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC	NCT05910034	Advanced Non-Sm...	Trilaciclib+Env... Envafolimab+Doc... Docetaxel	18 Years -	Fudan University
Study of Trilaciclib and Lurbinectidin	NCT05578326	Lung Cancer Small-cell Lung...	Trilaciclib Lurbinectedin	18 Years -	UNC Lineberger Comprehensive Cancer Center
Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma	NCT06217003	Osteosarcoma	Trilaciclib	12 Years - 50 Years	The First Affiliated Hospital of Xinxiang Medical College
Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving Carboplatin Combined With Etoposide or Topotecan	NCT04902885	Extensive-stage...	Trilaciclib	18 Years -	Jiangsu Simcere Pharmaceutical Co., Ltd.
Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma	NCT06217003	Osteosarcoma	Trilaciclib	12 Years - 50 Years	The First Affiliated Hospital of Xinxiang Medical College

Spots Global Cancer Trial Database for trilaciclib

Every month we try and update this database with for trilaciclib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for trilaciclib

Every month we try and update this database with for trilaciclib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for trilaciclib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.