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Monoclonal Antibodies

Atezolizumab + IL-12 Gene Therapy for Non-Small Cell Lung Cancer

Phase 1
Recruiting
Research Sponsored by Eric Bernicker, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥4 weeks since any major surgery, completion of radiation therapy, or completion of all prior systemic anticancer therapy
Cardiac ejection fraction of ≥45%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing a new treatment for lung cancer that has progressed despite other treatments. The new treatment is a combination of atezolizumab and ADV/IL-12 gene therapy.

Who is the study for?
This trial is for adults with metastatic non-small cell lung cancer that worsened after first-line immunotherapy, with or without chemo. They must have a life expectancy of at least 6 months, measurable disease, and be able to provide biopsy tissue. Participants need to agree to use contraception and not have severe allergies, active infections, heart issues within the last 3 months, or other conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial tests Atezolizumab combined with ADV/IL-12 gene therapy in patients whose lung cancer has progressed despite treatment. It's a Phase I study focused on safety and requires participants' tumors to be accessible for gene therapy administration.See study design
What are the potential side effects?
Potential side effects may include allergic reactions related to antibodies or fusion proteins used in treatments, immune system complications due to gene therapy, as well as general risks associated with immunotherapies such as fatigue and inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It has been over 4 weeks since my last major surgery, radiation, or cancer treatment.
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My heart pumps blood effectively.
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I am willing to provide tissue samples for the study.
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My lung cancer has spread and was confirmed by a lab test.
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I am either male or female.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My tumor can be reached for treatment injections.
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My cancer has worsened despite initial immunotherapy.
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My blood and organs are functioning well.
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I agree to either not have sex or use a condom.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival plus stable disease after 6 cycles
Secondary outcome measures
Health-Related Quality-of-Life (HRQOL)
Overall Survival
Patient-reported outcomes (PRO)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Atezolizumab and Interleukin-12 Gene TherapyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Eric Bernicker, MDLead Sponsor
2 Previous Clinical Trials
11 Total Patients Enrolled
The Methodist Hospital Research InstituteLead Sponsor
270 Previous Clinical Trials
80,232 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,725 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04911166 — Phase 1
Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04911166 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Atezolizumab and Interleukin-12 Gene Therapy
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04911166 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a research endeavor such as this ever been attempted before?

"At present, 350 studies concerning Atezolizumab and Interleukin-12 Gene Therapy are live in 74 countries across 1646 cities. The exploration first began in 2008 with a phase 2 drug approval trial sponsored by Hoffmann-La Roche. This study involved 720 participants and since then, 81 have been concluded successfully."

Answered by AI

Has the FDA signed off on Atezolizumab and Interleukin-12 Gene Therapy?

"Due to the limited amount of clinical data available, Atezolizumab and Interleukin-12 Gene Therapy were assigned a score of 1 on our safety scale. This is consistent with it being an early Phase 1 trial."

Answered by AI

What is the participation rate for this medical trial?

"Affirmative. The clinical trial website indicates that this research project is actively recruiting participants, having been posted on October 14th 2021 and most recently updated March 9th 2022. 16 patients are required to be enrolled from one location."

Answered by AI

For what conditions is Atezolizumab and Interleukin-12 Gene Therapy commonly prescribed?

"Atezolizumab and Interleukin-12 Gene Therapy are primarily used to treat small cell lung cancer (sclc). However, these treatments can also be utilized for other malignant neoplasms, non-small cell lung carcinoma, and postoperative cases."

Answered by AI

Are there any openings for people to join this clinical trial?

"Clinicaltrials.gov reports that the medical trial remains open and was initially posted on October 14th 2021, with its latest update being made on March 9th 2022."

Answered by AI
~3 spots leftby Dec 2024