← Back to Search

Monoclonal Antibodies

switch sotorasib treatment until progression for Non-Small Cell Lung Cancer

Q: In how many distinct clinics is this experimental investigation currently being conducted?

<p>At present, Memorial Sloan Kettering Bergen (<a href="https://www.withpower.com/clinical-trials/all">All</a> Protocol Activities) in Montvale, Memorial Sloan Kettering Nassau (All Protocol Activities) in Uniondale, and Memorial Sloan Kettering Basking Ridge (All Protocol Activities) in Basking Ridge are among the 7 active recruitment sites for this trial.</p>

Phase 2

Recruiting

Led By Narek Shaverdian, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial will investigate if switching from durvalumab to sotorasib when minimal residual disease is detected is a better treatment for advanced lung cancer compared to staying on durvalumab.

Who is the study for?

This trial is for people with a type of lung cancer called locally advanced non-small cell lung cancer (LA-NSCLC). Participants should have minimal residual disease (MRD) detectable after initial treatment. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.Check my eligibility

What is being tested?

The study tests if switching from durvalumab to sotorasib when MRD is detected can better control LA-NSCLC compared to staying on durvalumab alone. It's about finding the most effective treatment timing and combination for this condition.See study design

What are the potential side effects?

While specific side effects aren't listed here, drugs like Durvalumab and Sotorasib may cause immune-related reactions, liver issues, fatigue, skin problems, shortness of breath among others. Side effects vary by individual.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 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 (PFS)

Secondary outcome measures

Incidence of dose-limiting toxicity (DLT)

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064

14%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Normal Hepatic Function

Moderate Hepatic Impairment

Severe Hepatic Impairment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: switch sotorasib treatment until progressionExperimental Treatment1 Intervention

Will receive sotorasib at 960 mg daily until progression. A dose de-escalation regimen based on toxicity will be implemented as below. If 120 mg cannot be tolerated, sotorasib will be discontinued and the patient will be removed from the trial.

Group II: continue standard of care (SOC) durvalumab treatmentActive Control1 Intervention

Will continue to receive durvalumab, 10 mg/kg IV every 2 weeks or 1500 mg/kg IV every 4 weeks for up to 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sotorasib

2021

Completed Phase 1

~370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,738 Total Patients Enrolled

AmgenIndustry Sponsor

1,371 Previous Clinical Trials

1,378,058 Total Patients Enrolled

Narek Shaverdian, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

102 Total Patients Enrolled

Frequently Asked Questions

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

Is this medical study currently open to new participants?

"As per the details available on clinicaltrials.gov, this research initiative is currently in search of eligible participants. The study was initially registered on March 20th, 2024 and has been recently updated on the same date."

Answered by AI

Has the FDA endorsed switching to sotorasib treatment until disease progression?

"The safety assessment for transitioning to sotorasib treatment until disease progression is rated 2 by the team at Power, as this study falls under Phase 2 and has preliminary safety data without evidence of effectiveness."

Answered by AI

In how many distinct clinics is this experimental investigation currently being conducted?

"At present, Memorial Sloan Kettering Bergen (All Protocol Activities) in Montvale, Memorial Sloan Kettering Nassau (All Protocol Activities) in Uniondale, and Memorial Sloan Kettering Basking Ridge (All Protocol Activities) in Basking Ridge are among the 7 active recruitment sites for this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)

2024. "A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06333678.

All > New York City > Philadelphia