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New drug switch may control lung cancer longer in High-Risk patients

NCT ID NCT06333678

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study looked at whether switching from the immunotherapy durvalumab to the targeted drug sotorasib can better control locally advanced non-small cell lung cancer in patients with a KRAS G12C mutation and signs of remaining cancer (minimal residual disease). Ten participants were randomly assigned to either switch to sotorasib or stay on durvalumab. The goal was to see if the switch could delay cancer progression or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Mar 2024

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Pre-Monitoring Phase * Histologic diagnosis of NSCLC * Locally advanced disease, defined as AJCC 8th Edition Stage III disease. * Plan for, currently receiving, or recently completed definitive chemoradiation. Definitive radiation is defined as 56-70 Gy in 28-35 fractions concurrently with one of the following chemotherapy regimens: * Carboplatin + pemetrexed * Cisplatin + pemetrexed * Paclitaxel + carboplatin * Cisplatin + etoposide * KRAS p.G12C mutation identified through molecular testing * Adequate hepatic function, with adequate function defined as AST and ALT \< 2.5 x the upper limit of normal (ULN) * Patient eligible for consolidative durvalumab therapy * ECOG Performance status 0 - 2. * Age ≥ 18 years. * Patients must have decision-making capacity to consent to the study. * Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 55 years old and no menses for 1\> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral salpingectomy OR history of bilateral oophorectomy) or must be willing to comply with contraception requirements. Monitoring Phase * Completed definitive chemoradiation. Definitive radiation is defined as 56-70 Gy in 28-35 fractions concurrently with one of the following chemotherapy regimens: * Carboplatin + pemetrexed * Cisplatin + pemetrexed * Paclitaxel + carboplatin * Cisplatin + etoposide * Detectable ctDNA measured within 8 weeks (+2 weeks) of completing definitive chemoradiation * No evidence of radiographic progression, as measured through SOC imaging, as deemed by principal investigator, including a CT scan of the chest * ECOG Performance status 0 - 2. * Plan to start or already started durvalumab consolidation Therapeutic Phase * No evidence of radiographic RECIST 1.1 progression, as measured through SOC imaging, as deemed by principal investigator, including a CT scan of the chest * MRD as measured by ctDNA testing (described above) * Candidate for sotorasib therapy * Must have a negative pregnancy test (serum or urine) within 3 days prior to the first dose of sotorasib (if assigned to Group 2). Exclusion Criteria: * Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator. * Pregnant or lactating women. * Physical limitation to undergo radiotherapy. * Other active malignancy (e.g. receiving active treatment) within the last year except for basal cell carcinoma of the skin and in situ malignancy even if without evidence of disease and patients on adjuvant hormonal therapies (e.g. breast, prostate), or bladder cancer with localized diseases * Prior pneumonitis

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604, United States

  • University of Miami (Data Collection Only)

    Miami, Florida, 33136, United States

  • University of Michigan (Data Collection Only)

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt University (Data Collection Only)

    Nashville, Tennessee, 37232, United States

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