AzTrials
AzTrials

NSCLC Stage IVPhase 3NCT06745908

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 Inhibitor Therapy

A Phase 3 study testing N-803, Tislelizumab and Docetaxel in people with NSCLC Stage IV, run by ImmunityBio, Inc. at 49 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
NSCLC Stage IV
What is being tested?
N-803, Tislelizumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
507 participants
Where
49 sitesin 3 countries
Study dates
1 Oct 2025to Jan 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 (approximately 6 months duration [± 2 weeks]). Participants who received anti-PD-1/anti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible.
  • 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, rearranged during transfection (RET), Kirsten Rat sarcoma (KRAS) and HER2.
  • 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 standard of care) for the participant's genomic alteration at the time of screening:
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  • 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 course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
  • 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, or the participant will not be allowed in the study.
  • Participants must also meet the inclusion criteria #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 and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device [IUD]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.
  • 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.
  • 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 (approximately 6 months duration [± 2 weeks]). Participants who received anti-PD-1/anti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible.
  • 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 exactly 1 line of prior CPI therapy. If that CPI is not approved for advanced NSCLC, then an approved alternative CPI will be used.
  • 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 targeted therapy or 2 or more if multiple lines of targeted therapies are approved in the region. Thus, participants must have exhausted regional Health Authority-approved targeted therapies for their specific AGA for first- or second-line NSCLC, then have acquired resistance to immune checkpoint therapy to be eligible. Participants must meet inclusion criteria #4.
  • 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 prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of study medication. Participants with asymptomatic brain metastases (ie, 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.
  • 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 and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device [IUD]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.
  • 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.

Who cannot join

  • 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 for 180 days.
  • 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 systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.
  • 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 ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.
  • 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.
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  • 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 = [(140 - age in years) × weight in kg × 1.00] / [72 × serum creatinine in mg/dL]
  • 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 interventional clinical trial during active participation in this clinical trial is not allowed.
  • 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
  • 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 thyroid replacement and diabetes requiring insulin. The participant must have been off treatment for 60 days.
  • 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 systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.
  • 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 systemic therapy; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.
  • 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], anti-hepatitis B surface antibody [anti-HBs], anti-hepatitis B core antibody [anti-HBc], or hepatitis B virus [HBV] DNA), and/or hepatitis C infection (as per hepatitis C virus [HCV] RNA) within 28 days of randomization. Participants are eligible if they:
  • 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:
  • HBV DNA viral load < 2,000 IU/mL. ii. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT < 3 ULN that are not attributable to HBV infection.
  • Start or maintain antiviral treatment if clinically indicated as per the Investigator.
  • Have been curatively treated for hepatitis.
  • 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 of the treating Investigator.
  • 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 > ULN.
  • 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 metastases.
  • 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] / [72 × serum creatinine in mg/dL]
  • 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 interventional clinical trial during active participation in this clinical trial is not allowed.
  • 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.

Trial locations and contacts

49 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Phillip Trieu contact

856-739-5609

Phillip.Trieu@immunitybio.com

Tamra Madenwald contact

Tamra.Madenwald@immunitybio.com

49 sites in 3 countries

United States32 sites, 30 recruiting

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

    Ryan Hanula, 404-778-5141, rhanula@emory.edu

    Jennifer Carlisle, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Clinical Trials Office, 8437929321, hcc-clinical-trials@musc.edu

    Mariam Alexander, MD

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

    Bree Kinne, kinnebm@ucmail.uc.edu

    Kerri McGovern, MD

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Mary Patton, 513-584-7698, cancer@uchealth.com

    Matthew Mirsky, MD

    Recruiting

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

    Jaya Gill, 213-266-5600, Jaya.Gill@cssifm.org

    Tara Seery, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Alexander Spira, MD

    Recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Georges Azzi, MD

    Recruiting

  • The Oncology Institute of Hope and Innovation

    Fort Lauderdale, Florida, 33316

    kylee charlemagne, kylee.charlemagne@heliosclinical.com

    Edward S Santos, MD

    Recruiting

  • Lee Health

    Fort Myers, Florida, 33905

    Anthony Minichiello, 239-343-9660, Anthony.Minichiello@leehealth.org

    Leandro Moraes, MD

    Recruiting

  • Florida Oncology & Hematology

    Fort Myers, Florida, 33912

    Shivtaj Mann, DO, 239-264-7026, alina.ward@aoncology.com

    Shivtaj Mann, DO

    Recruiting

  • MemorialCare - Orange Coast Medical Center

    Fountain Valley, California, 92708

    Alexis Wilson, AWilson4@memorialcare.org

    Amol Rao

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Yebin Kwon, 714-992-3000 ext. x 2279, yebin.kwon@providence.org

    David J Park, MD

    Recruiting

  • OPN Healthcare INC

    Glendale, California, 91203

    Completed

  • Carolina Oncology Specialists

    Hickory, North Carolina, 28602

    Augustina Ekhaiyeme, 704-342-1900 ext. Ext 1126, aekhaiyeme@carolinaonco.com

    Justin Favaro, MD

    Recruiting

  • Hawaii Cancer Care

    Honolulu, Hawaii, 96813

    Juliette Powell, (808) 539-2273 ext. 114, Juliette.Powell@Aoncology.com

    David J Tamura, MD

    Recruiting

  • Genesis Cancer and Blood Institute

    Hot Springs, Arkansas, 71913

    Laura Sellers, BSN, RN, 501.624.7700 ext. 63839, Laura.sellers@aoncology.com

    Roy T Webb, MD

    Recruiting

  • Hematology Oncology of Indiana

    Indianapolis, Indiana, 46260

    Robin Wilson, 520-836-9800 ext. 69937, robin.wilson@aoncology.com

    Ruemu E Birhiray, MD

    Recruiting

  • City of Hope

    Irvine, California, 92618

    Lee Hong, MD, 949- 283-4255, lehong@coh.org

    Lee Hong, MD

    Recruiting

  • OPN Healthcare INC/ Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Completed

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

    Renee Dickerson, 866-213-3025, BHSResearch@BHSI.com

    Wangjian Zhong, MD

    Recruiting

  • Sylvester Comprehensive Cancer Center at Miami University

    Miami, Florida, 33136

    Ricardo Samayoa, 305-243-9848, res335@miami.edu

    Lawrence M Negret, MD

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Wade Iams, MDD

    Recruiting

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee, 37232

    Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO), CTIP@VUMC.org

    Shuai Wang, MD

    Recruiting

  • Baptist Health Floyd

    New Albany, Indiana, 47150

    Tasha Dotson Dotson, 866-213-3025, BHSResearch@BHSI.com

    Jasdeep Sidhu, MD

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Patrice Jones, 949-764-4577, patrice.jones@hoag.org

    Chaitali Nangia, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

    Massey CTO Lung Team, 8046286430, masseylung@vcu.edu

    Jonathan Berkman, MD

    Recruiting

  • Woodlands Cancer Institute

    Shenandoah, Texas, 77384

    Yamile A Anaya, (936) 235-7092 ext. 70260, Yamile.AbuchardAnaya@aoncology.com

    Krishna K Pachipala, MD

    Recruiting

  • Medical Oncology Associates - Summit Cancer Centers

    Spokane, Washington, 99208

    Arvind Chaudhry, MD

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Amber Hixon, 479-313-6810, Ahixon@hogonc.com

    Eric Schaefer, MD

    Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

    Adrianna Moore, RN, 417-882-4880, adrianna.moore@aoncology.com

    Viran R Holden, MD

    Recruiting

  • Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis)

    St Louis, Missouri, 63110

    Skye Anderson-Gierse, (314) 273-6693, skye@wustl.edu

    Daniel Morgensztern

    Recruiting

  • Moffit Cancer Center

    Tampa, Florida, 33612-9497

    Erika Gonzalez, Erika.Gonzalez@moffitt.org

    Andreas Saltos, MD

    Recruiting

Other trials in United States

United Kingdom10 sites, 10 recruiting

  • Belfast Health and Social Care Trust - Belfast City Hospital

    Belfast, Antrim, BT9 7AB

    Eimear Nicholl, +44 2890329241, eimear.nicholl@belfasttrust.hscni.net

    Lynn Campbell, MB ChB, MRCP

    Recruiting

  • University Hospital Birmingham NHS Trust

    Birmingham, West Midlands, B9 5SS

    Lisa-Marie Brueton, +44 1214242000, Lisa-Marie.Brueton@uhb.nhs.uk

    Shobhit Baijal, MBBS, MRCP

    Recruiting

  • Betsi Cadwaladr University Health Board - Glan Clwyd Hospital

    Bodelwyddan, Denbighshire, LL18 5UJ

    Angel Garcia, +44 3000843843, angel.garcia@wales.nhs.uk

    Angel Garcia, LMS

    Recruiting

  • Velindre NHS Trust - Velindre Cancer Centre VCC

    Cardiff, Glamorgan, CF14 2TL

    Laurie Jones, +44 2920615888, Laurie.Jones6@wales.nhs.uk

    Paul Shaw, FRCP, FRCR, PhD

    Recruiting

  • NRS South-East Cancer Research Network

    Edinburgh, Midlothian, EH4 2XR

    Colin Barrie, +44 1315371000, Colin.Barrie@nhs.scot

    Colin Barrie, MBBS, MRCP

    Recruiting

  • Royal Surrey County Hospital NHS Foundation Trust - St Lukes Cancer Centre

    Guildford, Surrey, GU2 7XX

    Ajay Mehta, +44 1483571122, amehta3@nhs.net

    Ajay Mehta, MBBS, MS, FACS

    Recruiting

  • Royal London Hospital

    London, Greater London, NW3 2QG

    Alpha Cham, +44 2077940500, Alpha.Cham@nhs.net

    Ekaterini Boleti, MD, PhD, FRCP

    Recruiting

  • Southampton General Hospital, Southampton University Hospital National Health Service Trust

    Southampton, Hampshire, SO16 6YD

    Rebecca Schofield, +44 02380777222, rebecca.schofield@uhs.nhs.uk

    Judith Cave, MRCP, MD, FRCP

    Recruiting

  • Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

    Grant Stewart, +44 1872250000, grantstewart1@nhs.net

    Grant Stewart, MBBS, MRCP, FRCR

    Recruiting

  • Betsi Cadwaladr University Health Board Wrexham Maelor Hospital

    Wrexham, Wrexham, LL13 7TD

    Simon Gollins, +44 3000847847, simon.gollins@wales.nhs.uk

    Simon Gollins, BMBCh DPhil MRCP FRCR

    Recruiting

Other trials in United Kingdom

Canada7 sites, 7 recruiting

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

    Banita Aggarwal, +1 905-494-2120, Banita.Aggarwal@williamoslerhs.ca

    Kristin Perdrizet, MD

    Recruiting

  • Waterloo Regional Health Network - Midtown

    Kitchener, Ontario, N2G 1G3

    Niharika Shah, +1 519-749-4370, Niharika.Shah@wrhn.ca

    Mario Valdes, MD. FRCPC

    Recruiting

  • London Health Sciences Centre - Verspeeten Family Cancer Centre

    London, Ontario, N6A 5W9

    Tom Chen, +1 519-685-8500, Tom.Chen@lhsc.on.ca

    Daniel Breadner, MD. FRCPC, MSc, Bsc

    Recruiting

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

    Grace Bent, +1 905-895-4521, gbent@southlake.ca

    Shaqil Kassam, MSc, MD, FRCPC

    Recruiting

  • Vancouver Coastal Health

    North Vancouver, British Columbia, V7L 2L7

    Valla Sahraei, +1 604-988-3131, valla.sahraei@vch.ca

    Puneet Bains, MD, FRCPC

    Recruiting

  • Horizon Health Network - Saint John Regional Hospital (SJRH)

    Saint John, New Brunswick, E2L 4L2

    Carrie Folkins, +1 506-648-6890, Carrie.Folkins@horizonNB.ca

    James Michael, BSc, MD, MA, FRCPC

    Recruiting

  • University of Windsor

    Windsor, Ontario, N8W 1L9

    Kailey Huot, +1 519-254-5577, Kailey.Huot@wrh.on.ca

    Deepro Chowdhury, B.A., MD, FRCPC

    Recruiting

Other trials in Canada

About this study

Official title: Randomized, Two-Cohort, Open-Label, Phase 3 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 Inhibitor Therapy

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. For cohort A, the randomization will be stratified by geographical region (North America vs Europe vs Asia vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (epidermal growth factor receptor [EGFR]/anaplastic lymphoma kinase [ALK]/ROS proto-oncogene 1, receptor tyrosine kinase [ROS1] vs Other AGA vs No AGA).

For cohort B, the randomization will be stratified by geographical region (Americas vs Asia Pacific [PAC] vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (Yes vs No).

Conditions
NSCLC Stage IV
Being tested
N-803, Tislelizumab, Docetaxel, Prior failed checkpoint inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-803Drug

    N-803 1.2 mg SC

  • TislelizumabDrug

    Tislelizumab 200 mg IV

  • DocetaxelDrug

    Docetaxel 75 mg/m2 IV

  • Prior failed checkpoint inhibitorDrug

    Previously failed checkpoint inhibitor

Study groups in NCT06745908
Study groupRoleWhat they receive
Cohort A: Experimental ArmExperimental3-week cycles. N803, Tislelizumab, and Docetaxel will be administered on Cycle 1 and 2. N803 and Tislelizumab will be administered on Cycle 3 and onward until end of study.
Receives: Drug: N-803; Drug: Tislelizumab; Drug: Docetaxel
Cohort A: Control ArmActive comparatorThe control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV.
Receives: Drug: Docetaxel
Cohort B: Experimental ArmExperimental3-week cycles. N803, prior failed checkpoint inhibitor, and Docetaxel will be administered on Cycle 1 and 2. N803 and prior failed checkpoint inhibitor will be administered on Cycle 3 and onward until end of study.
Receives: Drug: N-803; Drug: Docetaxel; Drug: Prior failed checkpoint inhibitor
Cohort B: Control ArmActive comparatorThe control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV.
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare Overall Survival between the experimental and control arms

    Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start1 Oct 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
507 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06745908
Sponsor's protocol ID
ResQ201A-NSCLC
Status last verified
Oct 2025
First submitted
17 Dec 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing N-803, Tislelizumab and Docetaxel in people with NSCLC Stage IV, run by ImmunityBio, Inc. at 49 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 74 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Phillip Trieu (856-739-5609, Phillip.Trieu@immunitybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare Overall Survival between the experimental and control arms (time frame: Approximately 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06745908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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