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

Sponsor: NeoImmuneTech

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04984811

Patient View

This Phase II study assesses the efficacy and safety of NT-I7 with atezolizumab in untreated, PD-L1-expressing NSCLC. Eligible participants have Stage III/IV NSCLC, measurable disease, and ECOG 0-1. NT-I7 is given IM every 6 weeks, and atezolizumab IV every 3 weeks, for up to 35 cycles. Participants must provide a biopsy for PD-L1 assessment and have adequate organ function.

Patient Parameters

Program Overview

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.

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

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