Myeloprotection With Trilaciclib in Pan-cancer Population

NCT ID: NCT06297811

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

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

Study Design

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

Study Groups

Trilaciclib group

Group Type: EXPERIMENTAL

Trilaciclib Injection

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

Drug: Paclitaxel 175 mg/m\^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.

Carboplatin

Intervention Type: DRUG

area under curve(AUC) 5\~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles.

Control group

Group Type: ACTIVE_COMPARATOR

Paclitaxel

Intervention Type: DRUG

Drug: Paclitaxel 175 mg/m\^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.

Carboplatin

Intervention Type: DRUG

area under curve(AUC) 5\~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles.

Interventions

Trilaciclib Injection

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

Intervention Type: DRUG

Paclitaxel

Drug: Paclitaxel 175 mg/m\^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.

Intervention Type: DRUG

Carboplatin

area under curve(AUC) 5\~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles.

Intervention Type: DRUG

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.

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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Rui-hua Xu, MD, PhD

President and Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Ruihua Xu, PhD

Role: CONTACT

xurh@sysucc.org.cn

+86-13922206676

Yanxia Shi

Role: CONTACT

shiyx@sysucc.org.cn

+86-13609058827

Other Identifiers

SMA PT 001

Identifier Type: -

Identifier Source: org_study_id