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

Part of paid clinical trials in Miami, Florida.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06333678
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    10 mg/kg IV every 2 weeks or 1500 mg/kg IV every 4 weeks for up to 12 months.
  • Sotorasib — DRUG
    960 mg, Patients who do not tolerate sotorasib at 960 mg can be dose reduced to 120 mg.

Study Details

In this study, the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC). The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab (and not switching to sotorasib).

Key Dates

Start date
Mar 20, 2024
Status verified
Jan 2026
Primary completion
Jan 27, 2026
Completion
Jan 27, 2026

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: continue standard of care (SOC) durvalumab treatment
    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.
  • Experimental: switch sotorasib treatment until progression
    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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: up to 3 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Miami (Data Collection Only)MiamiFlorida33136-
University of Michigan (Data Collection Only)Ann ArborMichigan48109-
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553-
Vanderbilt University (Data Collection Only)NashvilleTennessee37232-

Find similar trials in Miami, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Miami (Data Collection Only)· Miami, FLUniversity of Michigan (Data Collection Only)· Ann Arbor, MIMemorial Sloan Kettering Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (All Protocol Activities)· Commack, NY

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