Study Summary
This trial will study if ctDNA can help predict which NSCLC patients need immunotherapy and/or chemo to treat their cancer.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Duration of time from first treatment to time of death, up to 36 months
All analyses will be conducted using the 30-day safety window
Safety and Tolerability
Month 36
Duration of Response
Duration of time between the date of first treatment and the date of objectively documented progression per irRECIST or the date of initiation of palliative local therapy or the date of subsequent anti-cancer therapy, whichever occurs first, up to 36 mo
Objective Response Rate
Month 36
Overall Survival
Month 36
Progression Free Survival on Subsequent line of therapy (PFS2)
Month 36
Progression Free Survival (PFS)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Arm A
1 of 1
Active Control
108 Total Participants · 1 Treatment Group
Primary Treatment: Arm A · No Placebo Group · Phase 2
Arm AActiveComparator Group · 5 Interventions: Carboplatin, Nivolumab, Ipilimumab, Pemetrexed, Paclitaxel · Intervention Types: Drug, Drug, Drug, Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: duration of time from first treatment to time of death, up to 36 months
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
119 Previous Clinical Trials
26,600 Total Patients Enrolled
MedSIROTHER
39 Previous Clinical Trials
34,470 Total Patients Enrolled
Martin Gutierrez, MDPrincipal InvestigatorHackensack Meridian Health
1 Previous Clinical Trials
100 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 17 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are expected to live for at least 12 more weeks.
You are willing to have your blood tested multiple times to monitor your response to treatment.
References
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Frequently Asked Questions
What is the current status of Arm A in terms of FDA validation?
"Our company has given Arm A a score of 2, as there is limited evidence that this drug can be safely administered, but no data to suggest its efficacy." - Anonymous Online Contributor
Unverified Answer
Are there remaining vacancies in this research investigation?
"As indicated on clinicaltrials.gov, the study which was initially published on February 15th 2023 has ceased recruitment of participants and is no longer accepting applications. However, there are 1329 other trials currently enrolling patients worldwide." - Anonymous Online Contributor
Unverified Answer