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Trial record 1 of 1 for:    NCT04984811
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NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

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ClinicalTrials.gov Identifier: NCT04984811
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : May 13, 2022
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
NeoImmuneTech

Brief Summary:
This is a multicenter, open-label, single-arm Phase II study to evaluate anti-tumor efficacy and safety of NT-I7 in combination with atezolizumab in subjects with PD-L1-expressing (TPS ≥ 1%), metastatic (Stage IV) or locally advanced squamous or non-squamous NSCLC who have not received prior systemic therapy in the metastatic or locally advanced setting. Eligible subjects must have measurable disease according to RECIST 1.1. This Phase II study will enroll up to 83 subjects.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Non-Small Cell Lung Cancer Non-Small Cell Lung Carcinoma Nonsmall Cell Lung Cancer Non Small Cell Lung Cancer Drug: efineptakin alfa Drug: Atezolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Single-arm Phase II Study to Evaluate Anti-tumor Efficacy and Safety of NT-I7 in Combination With Atezolizumab in Subjects With Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
Actual Study Start Date : November 3, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NT-I7 and atezolizumab
Participants with no prior systemic therapy for advanced NSCLC will receive 1200 μg/kg NT-I7 IM on Day 1 and every 6 weeks and atezolizumab IV 1200 mg every 3 weeks until disease progression.
Drug: efineptakin alfa
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years).
Other Name: NT-I7

Drug: Atezolizumab
1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years).
Other Name: Tecentriq




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: approximately 2 years ]
    The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 as determined by the investigator.


Secondary Outcome Measures :
  1. Duration of response (DoR) [ Time Frame: approximately 2 years ]
    Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 as determined by the investigator.

  2. Disease Control Rate (DCR) [ Time Frame: approximately 2 years ]
    The proportion of subjects with a best overall response of CR, PR or SD, per RECIST 1.1 as determined by the investigator.

  3. Progression Free Survival (PFS) [ Time Frame: approximately 2 years ]
    The time from the first study treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first, per RECIST .1.1 as determined by the investigator.

  4. Overall survival (OS) [ Time Frame: approximately 2 years ]
    The time from first study treatment (Cycle 1, Day 1) to death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have histologically or cytologically confirmed metastatic or locally advanced NSCLC, and have not received prior systemic therapy. Subjects with locally advanced disease must have Stage III NSCLC and are not candidates for surgical resection or definitive chemoradiation
  • Tumor PD-L1 expression (TPS≥1%) as determined by PD-L1 22C3 immunohistochemistry local or central assay.
  • Have measurable disease
  • Agree to provide screening biopsy (or archival tissue) at screening to assess PD-L1
  • ECOG 0-1
  • Adequate hematologic and end organ function

Exclusion Criteria:

  • Prior systemic anti-cancer therapy
  • NSCLC with EGFR, or ALK, or BRAF or ROS or RED or other genomic tumor aberrations which have available therapy
  • Prior radiotherapy within 2 weeks of start of study treatment
  • Known active CNS metastasis or carcinomatous meningitis
  • Severe reactions to mAbs or IV immunoglobulin preparations
  • Autoimmune disease history in past two years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984811


Contacts
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Contact: Jean Fan, MD 301-337-2283 NIT119@neoimmunetech.com; jfan@neoimmunetech.com

Locations
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United States, Alabama
University of South Alabama Not yet recruiting
Mobile, Alabama, United States, 36604
Contact: Pamela Francisco    251-445-9870    pfrancisco@health.southalabama.edu   
Contact: Brian E Persing, MD    251-665-8000    bpersing@health.southalabama.edu   
Principal Investigator: Brian E Persing, MD         
United States, California
Innovative Clinical Research Institute (ICRI) Recruiting
Whittier, California, United States, 90603
Contact: Kirsten Bettino, CCRP    562-693-4477    kbettino@airesearch.us   
Contact: Sami Ali, MD    (562) 652-6532    sami.ali@airesearch.us   
Principal Investigator: Sami Ali, MD         
United States, Connecticut
Eastern CT Hematology & Oncology Associates Withdrawn
Norwich, Connecticut, United States, 06360
United States, Florida
Florida Cancer Specialists - South Research Office Recruiting
Fort Myers, Florida, United States, 33916
Contact: Rayanne Thompson    239-236-5681    rthompson@flcancer.com   
Contact: Fadi Kayali, MD       fkayali@flcancer.com   
Principal Investigator: Fadi Kayali, MD         
BRCR Medical Center Recruiting
Plantation, Florida, United States, 33322
Contact: Vaneska Chacin    561-447-0614    vchacin@brcrglobal.com   
Contact: Harshad Amin, MD    561-447-0614    amin@brcrglobal.com   
Principal Investigator: Harshad Amin, MD         
Florida Cancer Specialists - North Research Office Recruiting
Saint Petersburg, Florida, United States, 33705
Contact: BJ Conklin    727-216-1143    bconklin@flcancer.com   
Contact: Vijay Patel, MD    727-216-1143    ViPatel@flcancer.com   
Principal Investigator: Vijay Patel, MD         
Florida Cancer Specialists - East Research Office Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Lynn Asuncion, CCRP    561-366-4100 ext 14753    lasuncion@flcancer.com   
Contact: Todd Gersten, MD    (561) 366-4100    tgersten@flcancer.com   
Principal Investigator: Todd Gersten, MD         
United States, Georgia
University Cancer and Blood Center Not yet recruiting
Athens, Georgia, United States, 30607
Contact: Nikki Cooper Pope, RN, OCN, CCRC    706-353-2990 ext 235    npope@universitycancer.com   
Contact: Fredrick Flynt, MD, FACP    706-353-2990    fflynt@universitycancer.com   
Principal Investigator: Fredrick Flynt, MD, FACP         
United States, Kentucky
Norton Cancer Institute Not yet recruiting
Louisville, Kentucky, United States, 40217
Contact: Beth Johnson    502-636-7845    Christine.Johnson@nortonhealthcare.org   
Contact: Muneeb A Choudry, MD    502-889-7319    muneeb.choudry@nortonhealthcare.org   
Principal Investigator: Muneeb A Choudry, MD         
United States, Louisiana
Hematology Oncology Clinic Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Aimee Alumbaugh, RN    225-761-3951    Aimee.Alumbaugh@aoncology.com   
Contact: Michael Castine, MD    225-767-0822    michael.castine@aoncology.com   
Principal Investigator: Michael Castine, MD         
United States, Ohio
Zangmeister Cancer Center Recruiting
Columbus, Ohio, United States, 43219
Contact: Nancy Zangmeister, RN, OCN, CCRC    614-383-6236    Nancy.Zangmeister@aoncology.com   
Contact: Jorge Rios-Perez, MD    (614) 383-6000    Jorge.Rios@aoncology.com   
Principal Investigator: Jorge Rios-Perez, MD         
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Matthew Crocker    503-418-9389    crockerm@ohsu.edu   
Contact: Jeremy P Cetnar, MD, MSHPR    503-494-8534    cetnarj@ohsu.edu   
Principal Investigator: Jeremy P Cetnar, MD, MSHPR         
United States, Tennessee
Tennessee Oncology - Chattanooga Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Mindy Jordan    432-622-6212    mindy.jordan@sarahcannon.com   
Contact: Davey Daniel, MD    432-622-6212    ddaniel@tnonc.com   
Principal Investigator: Davey B. Daniel, MD         
Thompson Cancer Survival Center Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ashley Lyons, RN    865-331-2586    awoodwa1@covhlth.com   
Contact: David Chism, MD    865-331-1720    dchism@covhlth.com   
Principal Investigator: David Chism, MD         
Tennessee Oncology - Nashville Recruiting
Nashville, Tennessee, United States, 37203
Contact: Jennifer Mantegani    615-329-7289    Jennifer.Mantegani@SarahCannon.com   
Contact: Melissa Johnson, MD    615-524-4195    mjohnson@tnonc.com   
Principal Investigator: Melissa Johnson, MD         
Sponsors and Collaborators
NeoImmuneTech
Roche Pharma AG
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Responsible Party: NeoImmuneTech
ClinicalTrials.gov Identifier: NCT04984811    
Other Study ID Numbers: NIT-119
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NeoImmuneTech:
Advanced
Metastatic
NSCLC
PD-L1
Atezolizumab
NT-I7
Non Small Cell Lung Cancer
Non-small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Nonsmall Cell Lung Cancer
efineptakin alfa
efineptakin
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Antineoplastic Agents