GMCI Plus Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
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|ClinicalTrials.gov Identifier: NCT04495153|
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : December 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Biological: Aglatimagene besadenovec||Phase 2|
This trial seeks to add GMCI to stage III/IV NSCLC patients who are on standard of care first line ICI with evidence that the treatment may not be optimal but have the potential for delayed clinical benefit such that continuing the ICI is indicated. Studies of first line ICI have shown that most patients that will respond, respond in the first few weeks of treatment. However, a small percentage of patients have a delayed response with ICI. GMCI has been shown to increase the response rate to ICI in animal studies. Safety and potential efficacy of GMCI has been seen in clinical trials in over 650 patients with cancer (lung, pancreas, brain and ovarian). The goal of this study is to evaluate if adding GMCI can increase the percentage of patients that respond to the continued ICI. Patients may receive whatever standard of care therapy is indicated for their disease, such as maintenance chemotherapy, bevacizumab or focal radiation, in addition to continuing ICI. The eligibility criterion for determining that the ICI may not be working is based on time on ICI and response status with 3 cohorts as follows:
Cohort 1 is for patients with stable disease at least 18 weeks after starting ICI treatment, thus they have radiographic stable disease and clinically are stable but appear to have disease that is not responding further.
Cohort 2 is for patients with evidence of radiographic progression at least 18 weeks after starting ICI treatment but who are clinically stable. Examples that would fit this cohort would be patients that have disease that decreased or was stable with initial ICI therapy, and then is slowly progressing or a new distant lesion appears on imaging, but the patient is otherwise clinically stable.
Cohort 3 is for patients who have new lesions or progression of existing lesions at least 9 weeks after starting ICI but who are clinically stable.
The specific ICI treatment regimen on this protocol is not specified to allow for different standard of care options with or without chemotherapy; for example, pembrolizumab alone, pembrolizumab plus chemotherapy, atezolizumab or atezolizumab plus chemotherapy. In addition, it allows stage III patients after chemoradiation who may be on durvalumab as their standard of care. For example, a stage III patient may be eligible for cohort 2 if they have radiographic progression but are clinically stable 18 weeks after starting durvalumab or cohort 3 if they develop a new lesion at 12 weeks after starting durvalumab.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||111 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study is a phase II prospective study to evaluate the safety and potential efficacy of GMCI added to standard of care immune checkpoint inhibitor (ICI) therapy in stage III/IV NSCLC|
|Masking:||None (Open Label)|
|Official Title:||GMCI Plus Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients|
|Actual Study Start Date :||October 13, 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2024|
Cohort 1 - persistent but stable disease at least 18 weeks after starting ICI treatment
Cohort 2 - radiographic progressive disease at least 18 weeks after starting ICI treatment
Cohort 3 - refractory disease defined as progressed by imaging at least 9 weeks after starting ICI treatment
Biological: Aglatimagene besadenovec
Two courses of GMCI each involving aglatimagene besadenovec injection into an accessible involved tumor site followed by 14 days of oral valacyclovir. Patients will continue standard of care immune checkpoint inhibitor with or without chemotherapy.
- Response rate [ Time Frame: 12 months ]Tumor response as measured by RECIST criteria
- Safety graded by CTCAE version 5.0 [ Time Frame: 12 weeks ]Frequency of adverse events
- Changes in quantity of CD8 T cell subsets [ Time Frame: 6 months ]Blood and tumor will be evaluated for changes in immune response before and after GMCI
- Overall Survival (OS) [ Time Frame: 3 years ]The OS curves will be estimated using the Kaplan-Meier method.
- Progression Free Survival (PFS) [ Time Frame: 3 years ]The PFS curves will be estimated using the Kaplan-Meier method.
- Changes in patient-reported symptoms using the NSCLC-SAQ [ Time Frame: 12 months ]Non-small Cell Lung Cancer Symptoms Assessment Questionnaire (NSCLC-SAQ) score after compared to before treatment. The lowest score possible is 0, and the highest score possible is 20. Higher score indicates more severe symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495153
|United States, New York|
|NYU Langone Health||Recruiting|
|New York, New York, United States, 10016|
|Contact: Tasfiq Ullah 212-404-3682 Tasfiq.Ullah@nyulangone.org|
|Contact: Alexa DeMartino 516-663-1215 email@example.com|
|Principal Investigator: Daniel H. Sterman, MD FCCP, ATSF|