A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) (NCT06333678) | Clinical Trial Compass
CompletedPhase 2
A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)
United States10 participantsStarted 2024-03-20
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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…