Lokal İleri veya Metastatik Küçük Hücreli Dışı Akciğer Kanserinde AZD9291 (Osimertinib) ile Platin Bazlı İkili Kemoterapi Karşılaştırması

Sade dilde özet

Bu çalışma, EGFR hedefli tedavi sonrası ilerleyen ve EGFR geninde T790M mutasyonu taşıyan lokal ileri veya metastatik küçük hücreli dışı akciğer kanseri (non-small cell lung cancer) hastalarında Osimertinib (AZD9291) ilacını, platin bazlı ikili kemoterapiyle karşılaştırıyor. T790M pozitifliği merkezi olarak doğrulanmış hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

AstraZeneca

Müdahale

Chemotherapy, Cross-over to Osimertinib

Başlangıç

04.08.2014

Tahmini bitiş

15.12.2023

Ülkeler

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

İlgili genler

Merkezler

• 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

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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