A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 plus Chemotherapy versus Keytruda® plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants with Stage IV Non-squamous Non-small Cell Lung Cancer. - BAT-3306-002-CR

Bio-Thera Solutions Ltd.0 sites684 target enrollmentMarch 27, 2024

ConditionsStage IV Non-squamous non-small cell lung cancer MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864 Therapeutic area: Diseases [C] - Neoplasms [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Stage IV Non-squamous non-small cell lung cancer
Sponsor: Bio-Thera Solutions Ltd.
Enrollment: 684
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 27, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Bio-Thera Solutions Ltd.

Eligibility Criteria

Inclusion Criteria

•Male or female, age \=18 years on the day of signing informed consent., Have adequate organ function as indicated by the following laboratory values: Bone marrow reserve: • Absolute neutrophil count \=1\.5 × 109/L without growth factor support in the 2 weeks prior to study drug administration • Hemoglobin \=9 g/dL or \=5\.6 mmol/L without growth factor support and transfusion in 2 weeks prior to study drug administration • Platelet count \=100 × 109/L without growth factor support and transfusion in 2 weeks prior to study drug administration Hepatic function: • Total bilirubin \=1\.5 × the ULN or direct bilirubin \=1\.0×ULN for participants with total bilirubin levels\>1\.5×ULN. • AST and ALT \=2\.5 × ULN (or \=5 × ULN for participants with liver metastases). Renal function: • Calculated creatinine clearance (CrCL) \=50 mL/min (Cockroft\-Gault Equation: CGGFR\={\[140\-age (yrs.)] × weight (kg)/72×serum creatinine (mg/dL)]} × (0\.85 if female). Coagulation function: • Coagulation tests International normalized ratio (INR) or Prothrombin Time (PT) \=1\.5 × ULN, Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) \=1\.5 × ULN (INR in the range of 2\-3 is acceptable on oral anticoagulants)., Female of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required., Female of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study intervention (BAT3306, EU\-Keytruda®, or US\-Keytruda®) and through 180 days after last dose of chemotherapeutic agents as specified in the protocol. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant., Male participant with a female partner(s) of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study intervention through 120 days after the last dose of study intervention (BAT3306, EU\-Keytruda®, or US\-Keytruda®) and through 180 days after last dose of chemotherapeutic agents as specified in the protocol. Male participant with a pregnant partner must agree to use a condom; no additional method of contraception is required for the pregnant partner. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant., Must agree to adhere to the current state and national advice regarding minimizing exposure to COVID\-19 from the first Screening Visit until the EOS Visit., Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures., Life expectancy \=3 months., ECOG performance status \=1\., Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC., Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement, Have not received prior systemic treatment for their advanced/metastatic nsNSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease., Have provided tumor tissue from locations not radiated prior to biopsy; formalin\-fixed specimens after the participants have been diagnosed with metastatic disease

Exclusion Criteria

•Is pregnant or a nursing female., Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment., Known allergies, hypersensitivity, or intolerance to any of the study intervention or their excipients., Is on chronic systemic steroids. Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study., Is unable or unwilling to take folic acid or vitamin B12 supplementation, Has an active infection requiring therapy., Human immunodeficiency virus infection, syphilis, or active tuberculosis infection at Screening. Screening for HIV, syphilis, and tuberculosis will be performed according to local practice and local regulatory guidance., Active Hepatitis B or C. Only when HBV carriers without active disease (HBV DNA titer \< 1000 cps/mL or 200 IU/mL) or cured Hepatitis C (negative HCV RNA test) may be enrolled., Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study., Is, at the time of signing informed consent, a known regular user of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)., Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco\- or paracentesis) is eligible., Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible., Has a history of interstitial lung disease/ (non\-infectious) pneumonitis that required steroids or current interstitial lung disease/(non\-infectious) pneumonitis., Participants with a history of tissue or organ transplantation., Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months (at Screening), serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia)., History of poorly controlled hypertension or resting blood pressure \> 150/100 mmHg in the presence of a stable regimen of antihypertensive therapy., Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of the skin or pre\-invasive cancer of the cervix., Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the Investigator., Is currently participating and receiving an investigational agent or has participated in a study of an investigational agent and received an investigational agent or used an investigational device within 4 weeks prior to administration of the first dose of study intervention., Before the first dose of study intervention: • Had received prior systemic antineoplastic chem