Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04984811
Other study ID # NIT-119
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 3, 2021
Est. completion date March 2025

Study information

Verified date March 2024
Source NeoImmuneTech
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 83
Est. completion date March 2025
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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).
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).

Locations

Country Name City State
United States University Cancer and Blood Center Athens Georgia
United States TOI Clinical Research Cerritos California
United States Tennessee Oncology - Chattanooga Chattanooga Tennessee
United States Zangmeister Cancer Center Columbus Ohio
United States Renovatio Clinical - El Paso El Paso Texas
United States Summit Health Medical Center Florham Park New Jersey
United States Florida Cancer Specialists - South Research Office Fort Myers Florida
United States Goshen Center for Cancer Care Goshen Indiana
United States East Carolina University Greenville North Carolina
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Norton Cancer Institute Louisville Kentucky
United States University of South Alabama Mobile Alabama
United States Tennessee Oncology - Nashville Nashville Tennessee
United States Eastern CT Hematology & Oncology Associates Norwich Connecticut
United States Pikeville Medical Center, Inc. Pikeville Kentucky
United States BRCR Medical Center Plantation Florida
United States OHSU Knight Cancer Institute Portland Oregon
United States Florida Cancer Specialists - North Research Office Saint Petersburg Florida
United States TidalHealth Peninsula Regional, Inc. Salisbury Maryland
United States MaineHealth Cancer Care South Portland Maine
United States Renovatio Clinical - The Woodlands The Woodlands Texas
United States Florida Cancer Specialists - East Research Office West Palm Beach Florida

Sponsors (2)

Lead Sponsor Collaborator
NeoImmuneTech Roche Pharma AG

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. approximately 2 years
Secondary 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. approximately 2 years
Secondary 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. approximately 2 years
Secondary 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. approximately 2 years
Secondary Overall survival (OS) The time from first study treatment (Cycle 1, Day 1) to death from any cause. approximately 2 years
See also
  Status Clinical Trial Phase
Terminated NCT03087448 - Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Phase 1
Recruiting NCT05042375 - A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 3
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Terminated NCT05414123 - A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Recruiting NCT05009836 - Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03219970 - Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
Recruiting NCT05949619 - A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors Phase 1/Phase 2
Recruiting NCT04054531 - Study of KN046 With Chemotherapy in First Line Advanced NSCLC Phase 2
Withdrawn NCT03519958 - Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Terminated NCT02580708 - Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer Phase 1/Phase 2
Completed NCT01871805 - A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Terminated NCT04042480 - A Study of SGN-CD228A in Advanced Solid Tumors Phase 1
Recruiting NCT05919641 - LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
Completed NCT03656705 - CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma Phase 1