A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)

Summary

The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.

Timeline

Start

2021-09-12

Primary completion

2024-10-28

Completion

2027-06-02

Outcome

Met primary endpoint

registry MEDIAN Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin: 8.4 (5.75 to 11.83) Months NCT04765059 ↗

registry Hazard Ratio (HR) 0.43 (95% CI 0.27 to 0.70); Log Rank NCT04765059 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Osimertinib	Small molecule	80 mg	Oral
Comparator	Carboplatin	Small molecule	5 unknown	Intravenous
Comparator	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Comparator	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Indications