Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: N-803 1.2 mg SC
Tislelizumab 200 mg IV
: NIL
Intervention2: N-803 1.2 mg SC +
Tislelizumab 200 mg IV
: The treatment regimen for the experimental arm will be as follows. Agents are to b
Sponsors
ImmunityBio, Inc.
CBCC Global Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age equal to or greater than 18 years. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board or Independent Ethics Committee guidelines. 3. Pathologically confirmed stage four Non Small Cell Lung Cancer disease. 4. Have acquired resistance to an immune checkpoint inhibitor, defined as disease progression immediately following an initial response or stable disease of at least six months duration to exactly one line of anti Programmed Death Ligand one or anti Cytotoxic T Lymphocyte Associated Protein four therapy for stage three, stage four, or recurrent disease, given alone or in combination with chemotherapy. 5. Participants with actionable genomic alteration must have one or more documented actionable genomic alterations such as Epidermal Growth Factor Receptor, ROS Proto Oncogene one, Neurotrophic Tyrosine Receptor Kinase, B Rapidly Accelerated Fibrosarcoma, Mesenchymal Epithelial Transition exon fourteen skipping, Rearranged During Transfection, or Kirsten Rat Sarcoma. 6. Participants with actionable genomic alteration must meet the following criteria for advanced or metastatic Non Small Cell Lung Cancer: a. Participants with Epidermal Growth Factor Receptor L858R or exon nineteen deletion mutations must have received prior osimertinib. b. Participants who received a targeted agent as adjuvant therapy for early stage disease must have relapsed or progressed while on treatment or within six months of the last dose, or must have received at least one additional course of targeted therapy for the same genomic alteration for relapsed or progressive disease. c. Participants who have been treated with a prior tyrosine kinase inhibitor must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, otherwise the participant will not be allowed in the study. d. Participants must meet inclusion criterion number four listed above. 7. Eastern Cooperative Oncology Group performance status of zero to two, with measurable tumor lesions according to Response Evaluation Criteria In Solid Tumors version one point one. 8. Ability to attend required study visits and return for adequate follow up, as required by this protocol. 9. Agreement to practice effective contraception for female participants of child bearing potential and non sterile males. Female participants of child bearing potential must agree to use effective contraception for up to seven months after completion of therapy, and non sterile male participants must agree to use a condom for up to seven months after treatment. Effective contraception includes surgical sterilization such as vasectomy or tubal ligation, oral or injectable methods, two forms of barrier methods such as condom or diaphragm used with spermicide, intrauterine devices, and hormonal therapy. 10. Participants with known human immunodeficiency virus infection must be receiving antiretroviral therapy and have an undetectable viral load at their most recent viral load test within six months prior to enrollment.
Exclusion criteria
Exclusion criteria: Participants with ANY of the following criteria are excluded from participation in the study: 1. Systemic autoimmune disease currently requiring treatment such as lupus erythematosus, rheumatoid arthritis, Addison s disease, or autoimmune disease associated with lymphoma. The participant must have been off treatment for one hundred eighty days. 2. History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression, or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids, or a history of receiving systemic steroid therapy or any other immunosuppressive medication within three days prior to study initiation. Daily steroid replacement therapy such as prednisone or hydrocortisone and corticosteroids used to manage adverse events are permitted. 3. Participants with actionable genomic alteration of Anaplastic Lymphoma Kinase. 4. History of known active hepatitis B or hepatitis C infection. 5. Active infection requiring antibiotic therapy. 6. Active treatment with Cytochrome P450 three A four inhibitors. 7. Received a live vaccine within four weeks prior to the first dose of study drug or drugs. 8. History of or active inflammatory bowel disease such as Crohn s disease or ulcerative colitis. 9. Participants with known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate eighty. 10. Had major surgery within twenty eight days prior to study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating Investigator. 11. Inadequate organ function, evidenced by the following laboratory results: a. Absolute lymphocyte count smaller than the institutional lower limit of normal. b. Absolute neutrophil count smaller than one thousand five hundred cells per cubic millimeter. c. Platelet count smaller than one hundred thousand cells per cubic millimeter. d. Total bilirubin one point five times greater than the upper limit of normal, unless the participant has documented Gilbert s syndrome. e. Aspartate aminotransferase or alanine aminotransferase greater than one point five times the upper limit of normal. f. Alkaline phosphatase levels greater than two point five times the upper limit of normal. g. Hemoglobin smaller than nine point zero grams per deciliter. h. Serum creatinine greater than two point zero milligrams per deciliter or one hundred seventy seven micromoles per liter, or creatinine clearance smaller than forty milliliters per minute using the Cockcroft Gault formula below: Female equals open bracket one hundred forty minus age in years close bracket multiplied by weight in kilograms multiplied by zero point eight five divided by open bracket seventy two multiplied by serum creatinine in milligrams per deciliter close bracket. Male equals open bracket one hundred forty minus age in years close bracket multiplied by weight in kilograms multiplied by one point zero zero divided by open bracket seventy two multiplied by serum creatinine in milligrams per deciliter close bracket. 12. Have any of the following: a. Cirrhosis at a level of Child Pugh class B or worse. b. Cirrhosis of any degree and a history of hepatic encephalopathy. c. Clinically meaningful ascites resulting from cirrhosis. Cli
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare Overall survival between experimental and control arms Timepoint: Approx 4.9 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare immune disease control rate (iDCR), immune progression-free survival (iPFS), immune overall response rate (iORR), and immune duration of response (iDOR) as measured using immune Response Evaluation Criteria in Solid Tumors (iRECIST) between the experimental and control arms.Timepoint: Approx 4.9 years;Compare safety between experimental and control arms.Timepoint: Approx 4.9 years | — |
Countries
Australia, Belgium, Brazil, Canada, China, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, New Zealand, Poland, Republic of Korea, Romania, Serbia, Spain, Taiwan, United Kingdom, United States of America
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed