Studieoverzicht

Study name: KRYSTAL-21

Histology NSCLC
Tumor stage Stage IV
Host / recruiting sites Antoni van Leeuwenhoek
Enrollment Recruiting
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.