A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)
Completed · Phase 2
Conditions studied: Non-Small Cell Lung Cancer
In brief
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 facts
- Study ID
- NCT06333678
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 10
- Starts
- 2024-03-20
- Expected to finish
- 2026-01-27
- Last updated by the study team
- 2026-01-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Miami (Data Collection Only) — Miami, Florida, United States
- University of Michigan (Data Collection Only) — Ann Arbor, Michigan, United States
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack, New York, United States
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States
- Vanderbilt University (Data Collection Only) — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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