Phase I Trial of Atezolizumab and Interleukin-12 Gene Therapy in Metastatic Non-Small Cell Lung Cancer With Progression on First-Line Immunotherapy With or Without Chemotherapy

Phase 1

Suspended

• Conditions: Non-small Cell Lung Cancer
• Interventions: Combination Product: Atezolizumab and Interleukin-12 Gene Therapy

• Registration Number: NCT04911166
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

This is a Phase I study evaluating the safety of atezolizumab in combination with ADV/IL-12 gene therapy in patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on first-line immunotherapy with or without chemotherapy.

Detailed Description

This is a Phase I study evaluating the safety of atezolizumab in combination with adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on first-line immunotherapy with or without chemotherapy. Approximately 16 patients will be enrolled on the study. The primary endpoint will be the safety of the atezolizumab and ADV/IL-12 gene therapy combination and will be determined using the Bayesian model averaging-continual reassessment method (BMA-CRM). ADV/IL-12 will be intratumorally injected on Day 0 of the study. The starting dose of ADV/IL-12 will be 5 × 1011 vp. ADV/IL-12 dose level will de-escalate based on Dose Limiting Toxicity (DLT) occurrence: dose level -1, 3 × 1011 vp and dose level -2, 1 × 1011 vp. The starting dose, based on the dose range explored in prior studies, is expected to have activity and dosing changes are only in place in the event that toxicity is demonstrated. Starting on Day 2 of the study, atezolizumab will be administered at 1200 mg IV every 3 weeks (Q3W) for 2 cycles. Patients with stable disease or better after completion of 2 cycles of atezolizumab will continue to receive atezolizumab Q3W until disease progression, unacceptable toxicity, or up to 12 months.

Study Timeline

• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-02
• Study Start: 2021-10-14
• Primary Completion: 2024-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atezolizumab and Interleukin-12 Gene Therapy	Atezolizumab and Interleukin-12 Gene Therapy	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival plus stable disease after 6 cycles	12 weeks	The primary efficacy endpoint will be the progression-free survival (complete response, partial response) plus stable disease after 6 cycles of atezolizumab) of patients treated with atezolizumab and IL-12 gene therapy in metastatic non-small cell lung cancer with progression on first-line immunotherapy with or without chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcomes (PRO)	12 weeks	Patient-reported outcomes (PRO) of patients treated with atezolizumab and IL-12 gene therapy in metastatic non-small cell lung cancer with progression on first-line immunotherapy with or without chemotherapy
Overall Survival	12 weeks	Overall Survival of patients treated with atezolizumab and IL-12 gene therapy in metastatic non-small cell lung cancer with progression on first-line immunotherapy with or without chemotherapy.
Radiographic response rate	12 Weeks	Radiographic response rate of patients treated with atezolizumab and IL-12 gene therapy in metastatic non-small cell lung cancer with progression on first-line immunotherapy with or without chemotherapy
Health-Related Quality-of-Life (HRQOL)	12 weeks	Health-related quality-of-life of patients treated with atezolizumab and IL-12 gene therapy in metastatic non-small cell lung cancer with progression on first-line immunotherapy with or without chemotherapy

Trial Locations

Locations (1)

Houston Methodist Cancer Center; 🇺🇸 Houston, Texas, United States