BridgeMD
Compares treatment options for NSCLC Stage IV
Official title Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In
ClinicalTrials.gov ID: NCT06745908
What this study is testing
What is N-803?
N-803 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for nsclc stage iv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, two-cohort, open-label, phase 3, clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (cohort A) or prior failed Health Authority-approved antiprogrammed death-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) CPI and docetaxel (cohort B) versus docetaxel monotherapy (cohorts A and B). For each cohort, enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Eligibility Criteria: Women and men of all races and ethnic groups are eligible for this trial. Cohort A
- Age ≥ 18 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee...
- Pathologically confirmed stage IV NSCLC disease.
- Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately...
You likely can't join if
- Systemic autoimmune disease currently requiring treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease...
- History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome/toxic...
- History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial...
- Participants with AGA of ALK.
- History of known active hepatitis B or C infection to be assessed within 6 months prior to enrollment using locally accepted standard of care...
- Active infection requiring antibiotic therapy.
See the full eligibility criteria
Who can join
- Eligibility Criteria: Women and men of all races and ethnic groups are eligible for this trial. Cohort A
- Age ≥ 18 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Pathologically confirmed stage IV NSCLC disease.
- Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease...
- Participants with AGA must have 1 or more documented AGA(s): EGFR, ROS1, neurotrophic tyrosine receptor kinase (NTRK), B rapidly accelerated fibrosarcoma (BRAF), mesenchymal epithelial transition (MET) exon 14 skipping...
- Participants with AGA must meet the following criteria for advanced or metastatic NSCLC. Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved (and is...
- Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib.
- Participants who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose or received at least one additional...
- Participants who have been treated with a prior tyrosine kinase inhibitor (TKI) must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration...
- Participants must also meet the #4 listed above.
- ECOG performance status of 0 to 2.
- Measurable tumor lesions according to RECIST v1.1.
- Have a life expectancy of at least 3 months.
- Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche...
- Participants with known HIV infection must be receiving anti retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment.
What rules you out
- Systemic autoimmune disease currently requiring treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The participant must have been off treatment...
- History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and...
- 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...
- Participants with AGA of ALK.
- History of known active hepatitis B or C infection to be assessed within 6 months prior to enrollment using locally accepted standard of care measurements. (Resolved cases are allowed.)
- Active infection requiring antibiotic therapy.
- Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and/or spinal cord compression.
- Body weight ≤ 40 kg at screening.
- Active treatment with CYP3A4 inhibitors.
- Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).
- History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- Participants with known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.
- Had major surgery within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating Investigator.
- Inadequate organ function, evidenced by the following laboratory results:
- Absolute lymphocyte count \< institutional lower limit of normal (LLN) (ie, participant should have a normal lymphocyte count to enroll in the study).
- Absolute neutrophil count ≤ 1,500 cells/mm3.
- Platelet count ≤ 100,000 cells/mm3.
- Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × upper limit of normal (ULN) or direct bilirubin is \> ULN.
- Aspartate aminotransferase (AST [serum glutamic-oxaloacetic transaminase; SGOT]) or alanine aminotransferase (ALT [serum glutamic pyruvic transaminase; SGPT]) \> 1.5 × ULN.
- Alkaline phosphatase (ALP) levels \> 2.5 × ULN.
- Hemoglobin \< 9.0 g/dL.
- Serum creatinine \> 2.0 mg/dL or 177 μmol/L or creatinine clearance \< 40 mL/min (using the Cockcroft-Gault formula below): Female = [(140 - age in years) × weight in kg × 0.85] / [72 × serum creatinine in mg/dL] Male =...
- Have any of following:
- Cirrhosis at a level of Child-Pugh B (or worse);
- Cirrhosis (any degree) and a history of hepatic encephalopathy; or
- Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
- Participation in an investigational drug study within 21 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other...
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Pregnant and nursing women.
- History of allergic reactions to tislelizumab.
- History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.
- Confinement in an institution by order of a court or authority. Cohort B Inclusion Criteria:
- Age ≥ 18 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
- Pathologically confirmed stage IV NSCLC disease.
- Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease...
- Participants who receive an immune CPI as consolidation therapy after chemoradiation are eligible if they show progression or recurrence within 3 months of their last CPI and must have received at least 6 months of...
- If participants are positive for actionable genomic alteration (AGA), defined as a genomic alteration which has at least 1 regional Health Authority-approved targeted therapy. Participants MUST have received at least 1...
- Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and have no evidence of new or enlarging brain metastases and also are off steroids 3 days...
- ECOG performance status of 0 to 2.
- Measurable tumor lesion(s) according to RECIST v1.1.
- Have a life expectancy of at least 3 months.
- Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche...
- Participants with known HIV infection must be receiving antiretroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment. Exclusion Criteria:
- Autoimmune disease currently requiring systemic treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma) except for autoimmune thyroiditis needing...
- History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and...
- History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring active treatment with systemic steroids or other...
- Have an active or uncontrolled hepatitis B and/or hepatitis C infection and are positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen [HBsAg]...
- Have received hepatitis B vaccination with only anti-HBs positivity and no clinical signs of hepatitis.
- Have HbsAg+ with HBV infection for more than 6 months (ie, chronic HBV infection) meeting the following conditions: i. HBV DNA viral load \< 2,000 IU/mL. ii. Have normal transaminase values, or, if liver metastases are...
- Active infection requiring systemic antibiotic therapy (antiviral therapy is allowed).
- Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and/or spinal cord compression.
- Body weight ≤ 40 kg at screening.
- Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).
- Known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.
- Had major surgery, myocardial infarction, and/or cerebrovascular accident within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery or illness in the opinion...
- Inadequate organ function, evidenced by the following laboratory results:
- Absolute lymphocyte count \< institutional LLN (ie, participant should have a normal lymphocyte count to enroll in the study).
- Absolute neutrophil count ≤ 1,500 cells/mm3.
- Platelet count ≤100,000 cells/mm3.
- Total bilirubin \> 1.5 times the ULN, unless the participant has documented Gilbert's syndrome). Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × ULN or direct bilirubin is...
- Aspartate aminotransferase (AST [serum glutamic-oxaloacetic transaminase; SGOT]) or alanine aminotransferase (ALT [serum glutamic pyruvic transaminase; SGPT]) \> 1.5 × ULN or \> 5 times ULN for participants with liver...
- Alkaline phosphatase (ALP) levels \> 2.5 × ULN, \> 5 times ULN for participants with known bone metastases.
- Hemoglobin \< 9.0 g/dL.
- Creatinine clearance \< 40 mL/min (using the Cockcroft-Gault formula below): Female = [(140 - age in years) × weight in kg × 0.85] / [72 × serum creatinine in mg/dL] Male = [(140 - age in years) × weight in kg × 1.00] /...
- Have any of the following:
- Cirrhosis at a level of Child-Pugh B (or worse);
- Cirrhosis (any degree) and a history of hepatic encephalopathy; or
- Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
- Participation in an investigational drug study within 28 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other...
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Pregnant and nursing women.
- History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.
- Have a history of malignancy other than NSCLC, except:
- Adequately resected non-melanoma skin cancer; or,
- Curatively treated in situ disease or
- Other curatively treated solid tumors, with no evidence of disease for ≥ 3 years; or
- Hormone sensitive cancers treated only with hormone therapy.
- Other antineoplastic therapies intended to treat cancer, including herbal medicines or other prohibited concurrent medication(s) within 28 days prior to the start of treatment in the study.
- Confinement in an institution by order of a court or authority.
The study team makes the final eligibility decision.
Where it's taking place
- Springdale, Arkansas, United States
- El Segundo, California, United States
- Fountain Valley, California, United States
- Glendale, California, United States
- Los Alamitos, California, United States
- Fort Lauderdale, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- St Louis, Missouri, United States
- Hickory, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Fairfax, Virginia, United States
- Richmond, Virginia, United States
- Spokane, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Springdale, Arkansas, United States; El Segundo, California, United States; Fountain Valley, California, United States; Glendale, California, United States; Los Alamitos, California, United States; Fort Lauderdale, Florida, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.