A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: Cohort A1: ALK-Positive (alectinib arm)
  Participants will receive alectinib 600 mg orally twice daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first
• Active Comparator: Cohort A1: ALK-positive (durvalumab arm)
  Participants will receive 1500 mg of intravenous (IV) durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first
• Experimental: Cohort A2: ROS 1-positive (entrectinib arm)
  Participants will receive entrectinib 600 mg orally once daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first. Cohort A2 has been closed to enrollment.
• Active Comparator: Cohort A2: ROS 1-positive (durvalumab arm)
  Participants will receive 1500 mg of IV durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first Cohort A2 has been closed to enrollment.

Geprüfte Regime

• Alectinib:
  Participants will receive oral alectinib twice daily with food.
• Entrectinib:
  Participants will receive oral entrectinib once daily, with or without food.
• Durvalumab:
  Participants will receive IV durvalumab every 4 weeks.

Quelle: ClinicalTrials.gov