| Histology |
NSCLC, all subtypes
|
| Tumor stage |
Stage III - IV |
| Host / recruiting site 1 |
Antoni van Leeuwenhoek
|
Enrollment |
Closed
|
| Therapy line |
Later line (≥2L)
|
| Design |
Randomized
|
| Intervention |
- Adagrasib 600 mg BID without regard to food, or
- Adagrasib 400 mg BID with food.
|
| Key inclusion criteria |
- Receipt of prior treatment with a platinum (cisplatin or carboplatin)-containing regimen and an immune checkpoint inhibitor (ie, anti- PD-1/ PD-L1 inhibitor) administered concurrently or sequentially.
- Presence of measurable disease per RECIST version 1.1.
|
| Key exclusion criteria |
- Prior treatment with an agent targeting KRAS G12C (eg, sotorasib).
- Any of the following cardiac abnormalities:
a. Unstable angina pectoris or myocardial infarction within 6 months prior to randomization.
b. Symptomatic or uncontrolled atrial fibrillation within 6 months prior to randomization.
c. Congestive heart failure (CHF) ≥ New York Heart Association (NYHA) Class 3 within 6 months prior to randomization.
d. Prolonged QTc interval > 470 milliseconds during screening period
e. Family or medical history of congenital Long QT Syndrome.
- Patients are excluded if they have any of the following CNS lesions:
a. Any untreated brain lesions > 2.0 cm in size
b. Any brainstem lesions
c. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of > 10 mg of prednisone (or equivalent) prior to randomization.
d. Poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression.
|
