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NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
efineptakin alfa
Atezolizumab
Sponsored by
NeoImmuneTech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama
  • TOI Clinical Research
  • Florida Cancer Specialists - South Research Office
  • BRCR Medical Center
  • Norton Cancer Institute
  • Pikeville Medical Center, Inc.
  • Zangmeister Cancer Center
  • OHSU Knight Cancer Institute
  • Tennessee Oncology - Chattanooga
  • Thompson Cancer Survival Center
  • Tennessee Oncology - Nashville
  • Renovatio Clinical - El Paso
  • Renovatio Clinical - The Woodlands

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NT-I7 and atezolizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 and iRECIST as determined by the investigator.

Secondary Outcome Measures

Duration of response (DoR)
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 and iRECIST as determined by the investigator.
Disease Control Rate (DCR)
The proportion of subjects with a best overall response of CR, PR or SD, per RECIST 1.1 and iRECIST as determined by the investigator.
Progression Free Survival (PFS)
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 and iRECIST as determined by the investigator.
Overall survival (OS)
The time from first study treatment (Cycle 1, Day 1) to death from any cause.

Full Information

First Posted
July 14, 2021
Last Updated
October 23, 2023
Sponsor
NeoImmuneTech
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT04984811
Brief Title
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeoImmuneTech
Collaborators
Roche Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Non Small Cell Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NT-I7 and atezolizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
efineptakin alfa
Other Intervention Name(s)
NT-I7
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
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).
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 and iRECIST as determined by the investigator.
Time Frame
approximately 2 years
Secondary Outcome Measure Information:
Title
Duration of response (DoR)
Description
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 and iRECIST as determined by the investigator.
Time Frame
approximately 2 years
Title
Disease Control Rate (DCR)
Description
The proportion of subjects with a best overall response of CR, PR or SD, per RECIST 1.1 and iRECIST as determined by the investigator.
Time Frame
approximately 2 years
Title
Progression Free Survival (PFS)
Description
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 and iRECIST as determined by the investigator.
Time Frame
approximately 2 years
Title
Overall survival (OS)
Description
The time from first study treatment (Cycle 1, Day 1) to death from any cause.
Time Frame
approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
TOI Clinical Research
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Florida Cancer Specialists - South Research Office
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
BRCR Medical Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Pikeville Medical Center, Inc.
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Facility Name
Zangmeister Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Tennessee Oncology - Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Tennessee Oncology - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Renovatio Clinical - El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Facility Name
Renovatio Clinical - The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States

12. IPD Sharing Statement

Learn more about this trial

NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

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