A Single-arm, Open-label, and Multicenter Phase Ⅱ Study Designed to Evaluate the Efficacy and Safety of Rulonilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Shandong New Time Pharmaceutical Co., LTD1 site in 1 country84 target enrollmentMarch 1, 2023

ConditionsNon-small Cell Lung Cancer NSCLC PD-1

InterventionsF520 Pemetrexed Carboplatin Paclitaxel

DrugsF520 Pemetrexed Carboplatin Paclitaxel

Overview

Phase: Phase 2
Intervention: F520
Conditions: Non-small Cell Lung Cancer
Sponsor: Shandong New Time Pharmaceutical Co., LTD
Enrollment: 84
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, open-label, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of rulonilimab combined with chemotherapy in patients with advanced or metastatic non-small cell lung Cancer (NSCLC). Two cohorts were designed in this study: cohort 1 (non-squamous NSCLC) and cohort 2 (squamous NSCLC). About 84 patients with advanced or metastatic NSCLC plan to be enrolled in about 20 study sites of the study.

Registry

clinicaltrials.gov

Start Date

March 1, 2023

End Date

October 25, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shandong New Time Pharmaceutical Co., LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged ≥18 years;
•Understand and voluntarily sign the written informed consent form;
•Study population:
•Patients with histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC who cannot receive surgery or radical concurrent chemoradiotherapy, based on the "8th Edition of the TNM Classification for Lung Cancer" issued by the International Association for the Study of Lung Cancer (IASLC); Have not received any prior systemic anti-tumor therapy for advanced/metastatic disease; Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of stage IIIB, IIIC, IV.
•Without mutation of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS-1; Note: The results of blood tests alone were not accepted;
•With a life expectancy of more than 3 months;
•With at least one measurable lesion (extra nodal lesions: long diameter \> 10 mm, nodal lesions: long diameter \> 15 mm) confirmed by contrast-enhanced CT or MRI according to RECIST v1.1;
•Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1;
•Vital organ functions meet the following requirements (Reception of granulocyte colony-stimulating factor (G-CSF) or pegylated granulocyte colony-stimulating factor (PEG-G-CSF) or blood transfusion within 14 days prior to laboratory tests is not permitted for prophylactic use):
•Blood routine examination: absolute neutrophil count (ANC) ≥ 1.5×109/L, hemoglobin (HGB) ≥ 90g/L, platelet count (PLT) ≥ 100×109/L; Hepatic function: total bilirubin (TBIL) ≤ 1.5×ULN, and alanine transaminase (ALT) and aspartate amino transferase (AST) ≤ 2.5×ULN for all patients, or AST and ALT levels ≤ 5×ULN for patients with liver metastases; Renal function: serum creatinine (Cr) ≤ 1.5×ULN or clearance of creatinine (CCr) ≥ 60 mL/min (Cr \> 1.5×ULN); Coagulation function: international normalized ratio (INR) ≤ 1.5×ULN and Activated partial thromboplastin time (APTT) ≤ 1.5×ULN； Thyroid stimulating hormone (TSH) is within the normal range; If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) should be normal or abnormal without clinical significance;

Exclusion Criteria

•Cohort 1: Have a histologically confirmed diagnosis of NSCLC with predominant squamous cells; Patients with mixed histology are not allowed if there is small cell component in the specimen; Cohort2: Have a histologically confirmed diagnosis of NSCLC with predominant Non-squamous cells; Mixed tumors will be categorized by the predominant cell type; if small cell carcinoma, neuroendocrine carcinomas and sarcomas elements are present, the subject is ineligible; Patients with mixed histology are allowed if there is squamous component \>50% in the specimen.
•Has active central nervous system (CNS) metastases and/or carcinomatous meningitis in the past or during screening, except for the following cases:
•Subjects with asymptomatic brain metastases (i.e., no neurological symptoms, no requirements for corticosteroids, and no lesion \>1.5 cm) may participate but will require regular imaging of the brain as a site of disease; Subjects with adequate treatmen may participate provided they are clinically stable for at least 4 weeks, and his nervous system and other clinical symptoms can return to the baseline level at least 2 weeks before the first dose (Except for residual signs or symptoms related to CNS therapy).
•Subjects with spinal cord compression not curatively cured by surgery and/or radiotherapy.
•Had prior treatment with anti-PD-1, or PD-L1, or PD-L2, or CD137, or CTLA-4 antibody or fusion protein or any other antibodies or drugs that specifically target T cell co-stimulatory or checkpoint pathways.
•Have suffered from interstitial lung disease, non-infectious pneumonia or uncontrolled lung disease in the past 3 years, including but not limited to pulmonary fibrosis, acute lung disease, etc. (Except chemotherapy-induced interstitial lung disease that is currently asymptomatic).
•Patients with uncontrolled or severe cardiovascular diseases, such as Class II-IV congestive heart failure, unstable angina, myocardial infarction and other cardiovascular diseases assessed by New York Heart Association (NYHA), uncontrolled hypertension (systolic blood pressure ≥ 180mmHg and/or diastolic pressure ≥ 100mmHg), poorly controlled arrhythmia (Including QTc interval male ≥ 450 ms, female ≥ 470 ms) within 6 months before the first dose.
•Subjects with symptomatic ascites, pericardial effusion or pleural effusion whose clinical status is stable for more than 1 month after receiving treatment (including therapeutic chest X-ray or puncture) can be enrolled.
•Subjects who are using or have recently used (within 7 days before the first dose of study drug) aspirin therapy, or is unable to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) during the study. (apply to cohort 1)
•Is unable or unwilling to take folic acid or vitamin B12 supplementation; Is unable to take corticosteroids; (Apply to cohort 1)

Arms & Interventions

F520+Chemotherapy

Cohort 1: Treatment period (3 weeks/cycle): On the first day of each cycle, F520 (200 mg), pemetrexed and carboplatin were administered sequentially by intravenous infusion (at least 30 min between doses). Maintenance period (3 weeks/cycle): On the first day of each cycle, F520 (200 mg) and pemetrexed were administered sequentially by intravenous infusion (at least 30 min between doses). Cohort 2: Treatment period (3 weeks/cycle): On the first day of each cycle, F520 (200 mg), paclitaxel and carboplatin were administered sequentially by intravenous infusion (at least 30 min between doses). Maintenance period (3 weeks/cycle): On the first day of each cycle, F520 (200 mg) was administered sequentially by intravenous infusion (at least 30 min between doses).

Intervention: F520