Trial record 1 of 1 for:
NCT04984811
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04984811 |
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Recruitment Status :
Recruiting
First Posted : August 2, 2021
Last Update Posted : May 13, 2022
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Sponsor:
NeoImmuneTech
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
NeoImmuneTech
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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 |
| 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
MedlinePlus Genetics related topics:
Lung cancer
Drug Information available for:
Atezolizumab
| Arm | Intervention/treatment |
|---|---|
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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.
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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 :
- 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 :
- 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.
- 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.
- 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.
- Overall survival (OS) [ Time Frame: approximately 2 years ]The time from first study treatment (Cycle 1, Day 1) to death from any cause.
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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
| Contact: Jean Fan, MD | 301-337-2283 | NIT119@neoimmunetech.com; jfan@neoimmunetech.com |
Locations
| 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
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by NeoImmuneTech:
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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 Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Antineoplastic Agents |