New drug switch may control lung cancer longer in High-Risk patients
NCT ID NCT06333678
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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10 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Jan 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
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University of Miami (Data Collection Only)
Miami, Florida, 33136, United States
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University of Michigan (Data Collection Only)
Ann Arbor, Michigan, 48109, United States
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Vanderbilt University (Data Collection Only)
Nashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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- Two-Drug combo takes aim at Hard-to-Treat lung cancer