AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Plain-language summary

This study compares the drug Osimertinib (AZD9291) with platinum-based doublet chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer that progressed after EGFR-targeted therapy and carries a T790M mutation in the EGFR gene. It included patients with centrally confirmed T790M positivity. It was a Phase 3 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

AstraZeneca

Intervention

Chemotherapy, Cross-over to Osimertinib

Start date

8/4/2014

Estimated completion

12/15/2023

Countries

United States, Australia, Canada, China, France, Germany, Hong Kong, Hungary, Italy, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom

Related genes

Locations

• Anaheim, United States
• Orange, United States
• Santa Rosa, United States
• Norwalk, United States
• Gainesville, United States
• Orlando, United States
• Pembroke Pines, United States
• Atlanta, United States
• Park Ridge, United States
• Indianapolis, United States
• Marrero, United States
• Chevy Chase, United States
• Lebanon, United States
• Brick, United States
• New York, United States
• Hershey, United States
• Charleston, United States
• Houston, United States
• Lacey, United States
• Tacoma, United States
• Milwaukee, United States
• Darlinghurst, Australia
• Heidelberg, Australia
• Kogarah, Australia
• Nedlands, Australia
• Woolloongabba, Australia
• Edmonton, Canada
• Vancouver, Canada
• Halifax, Canada
• Ottawa, Canada
• Toronto, Canada
• Montreal, Canada
• Beijing, China
• Beijing, China
• Changchun, China
• Chongqing, China
• Chongqing, China
• Fuzhou, China
• Guangzhou, China
• Guangzhou, China

+110

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Subjects with histologically or cytologically documented NSCLC.
* Locally advanced or metastatic NSCLC
* Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment
* Eligible to receive treatment with the selected doublet-chemotherapy
* Central confirmation of T790M+ mutation status
* World Health Organization (WHO) performance status 0-1
* At least one lesion, not previously irradiated.

Exclusion Criteria:

* • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
* Treatment with more than one prior line of treatment for advanced NSCLC
* Treatment with an approved EGFR-TKI (e.g.,erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment
* Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
* Previous treatment with Osimertinib, or a 3rd generation EGFR TKI

For subjects who cross-over to Osimertinib:

* Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review.
* At least 14 days since last dose of platinum-based doublet chemotherapy