Myeloprotection With Trilaciclib in Pan-cancer Population

Trial Title: Myeloprotection With Trilaciclib in Pan-cancer Population

NCT ID: NCT06297811

Condition: Non-Small Cell Lung Cancer
Breast Cancer
Endometrial Cancer
Cervical Cancer
Head And Neck Squamous Cell Carcinomas

Conditions: Official terms:
Endometrial Neoplasms
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Carboplatin

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Trilaciclib Injection
Description: Experimental: trilaciclib group Intervention: Drug: Trilaciclib Injection [Cosela] 240 mg/m^2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day
Arm group label: Trilaciclib group

Intervention type: Drug
Intervention name: Paclitaxel
Description: Drug: Paclitaxel 175 mg/m^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.
Arm group label: Control group
Arm group label: Trilaciclib group

Intervention type: Drug
Intervention name: Carboplatin
Description: area under curve(AUC) 5~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles.
Arm group label: Control group
Arm group label: Trilaciclib group

Summary: The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are: - effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy - does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age ≥ 18 years; 2. Eastern Cooperative Oncology Group (ECOG) performance score 0-1; 3. Histologically or cytologically confirmed advanced or recurrent solid malignant tumors, including: - Unresectable stage III/IV non-small cell lung cancer (NSCLC); - Recurrent or metastatic breast cancer (BC); - Newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IC-IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer without further surgical planning before disease progression; or recurrent platinum-sensitive ovarian cancer (OC); - FIGO stage III-IV or recurrent endometrial cancer (EC), including endometrioid carcinoma and serous or clear cell carcinoma; - FIGO stage IVB (including persistent) or recurrent cervical cancer (CC) (≤ 1 prior platinum-based therapy) not amenable to radical surgery or radiotherapy; - Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (including primary lesions located in the larynx, oropharynx, hypopharynx, oral cavity, undifferentiated or poorly differentiated nasopharyngeal carcinoma, and salivary gland carcinoma), which is not suitable for further surgery or radiotherapy. 4. At least one measurable lesion according to RECIST version 1.1; 5. Received up to one prior systemic chemotherapy and no prior paclitaxel plus carboplatin chemotherapy; 6. Adequate organ function meeting the following criteria: (1) adequate bone marrow function: Hb ≥ 100 g/L (no ESA or blood transfusion within 14 days before the first dose); ANC ≥ 2 × 10^9/L (no G-CSF within 14 days before the first dose); platelet count ≥ 100 × 10^9/L (no rhTPO, rhIL-11 or platelet transfusion within 14 days before the first dose); (2) adequate liver and kidney function: alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula); (3) adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 55%; 7. Life expectancy ≥ 3 months; 8. Females of childbearing potential agree to practice reliable contraception during the clinical trial and have a negative serum or urine pregnancy test within 7 days prior to dosing; 9. Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up. Exclusion Criteria: 1. History of myeloid leukemia, myelodysplastic syndrome, or concomitant sickle cell disease; 2. Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiation or steroid therapy; 3. Received surgery or radiotherapy within 4 weeks prior to the first dose of study drug; 4. Receipt of any investigational drug ≤ 30 days or ≤ 5 half-lives (whichever is longer) prior to the first dose of study drug; 5. Platinum-resistant OC (refractory to 1 line of platinum-based chemotherapy or recurrent platinum-based chemotherapy within 6 months prior to the first dose of study drug); 6. Requires concurrent radiotherapy; 7. Known history of hypersensitivity to the drug components of this protocol; 8. Pregnant or lactating women; 9. Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Medical Oncology,Sun Yat-sen University Cancer Center

Address:
City: Guangzhou
Zip: 510060
Country: China

Start date: March 1, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06297811