Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Non Small Cell Lung Cancer
Conditions
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
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.
Interventions
DRUGefineptakin 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).
DRUGAtezolizumab
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).
Sponsors
Roche Pharma AG
NeoImmuneTech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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 and iRECIST as determined by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DoR) | 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 and iRECIST as determined by the investigator. |
| Disease Control Rate (DCR) | approximately 2 years | 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) | 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 and iRECIST as determined by the investigator. |
| Overall survival (OS) | approximately 2 years | The time from first study treatment (Cycle 1, Day 1) to death from any cause. |
Countries
United States
Outcome results
None listed