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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
Cardiac ejection fraction of ≥45%
Willing to provide biopsy tissue as required by the study
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 belowSelect...
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 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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I agree to either not have sex or use a condom.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Atezolizumab and Interleukin-12 Gene TherapyExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,009 Total Patients Enrolled
Eric Bernicker, MDLead Sponsor
2 Previous Clinical Trials
11 Total Patients Enrolled
The Methodist Hospital Research InstituteLead Sponsor
275 Previous Clinical Trials
80,529 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been over 4 weeks since my last major surgery, radiation, or cancer treatment.I have not had a severe infection in the last 4 weeks.My heart pumps blood effectively.You must test negative for HIV.You have a disease that can be measured using specific guidelines.I haven't taken any immune-weakening drugs in the last 2 weeks.I am willing to provide tissue samples for the study.You are expected to live for at least 6 more months.My lung cancer has spread and was confirmed by a lab test.I have not had serious heart problems in the last 3 months.You have had serious allergic reactions to certain types of medications in the past.I am either male or female.I have not received a live vaccine in the last 4 weeks.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I have had a previous transplant of stem cells or an organ.My tumor can be reached for treatment injections.I haven't taken any immune-boosting drugs in the last 4 weeks.You currently have or have had a condition that affects your immune system.My cancer has worsened despite initial immunotherapy.I don't have any health issues that would prevent me from taking a new drug.I have high calcium levels in my blood that are causing symptoms.I frequently need procedures to remove excess fluid from my chest or abdomen.I have a history of specific lung conditions without a known cause.I have active tuberculosis.I have had cancer spread to the lining of my brain and spinal cord.My cancer pain is not managed with current treatment.My blood and organs are functioning well.I have cancer that has spread to my brain or surrounding membranes.You are allergic to Chinese hamster ovary cell products or any part of the atezolizumab medicine.You are allergic to any part of the ADV/IL-12 treatment.I agree to either not have sex or use a condom.I have not had any other cancer in the last 2 years.You test negative for hepatitis B surface antigen (HBsAg) at screening.I am currently on medication for hepatitis B.I have previously received gene therapy.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab and Interleukin-12 Gene Therapy
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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