Asya-Pasifik Bölgesindeki Küçük Hücreli Dışı Akciğer Kanseri Hastalarında AZD9291'in Tek Kollu Faz II Çalışması

Sade dilde özet

Bu çalışma, Asya-Pasifik bölgesindeki lokal ileri veya metastatik küçük hücreli dışı akciğer kanseri (non-small cell lung cancer) hastalarında AZD9291 ilacını değerlendiren tek kollu bir çalışmadır. Çalışmaya, ameliyat veya radyoterapi ile tedavi edilemeyen ve önceki tedavide hastalığı ilerleyen 18 yaş üstü hastalar alınmıştır. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

AstraZeneca

Müdahale

AZD9291

Başlangıç

22.06.2015

Tahmini bitiş

28.11.2025

Ülkeler

Australia, China, South Korea

İlgili genler

Merkezler

• Kogarah, Australia
• Nedlands, Australia
• Woolloongabba, Australia
• Beijing, China
• Beijing, China
• Beijing, China
• Changchun, China
• Chengdu, China
• Chongqing, China
• Chongqing, China
• Fuzhou, China
• Haikou, China
• Hangzhou, China
• Hangzhou, China
• Hangzhou, China
• Harbin, China
• Jinan, China
• Nanjing, China
• Shanghai, China
• Shanghai, China
• Shanghai, China
• Wuhan, China
• Wuhan, China
• Xi'an, China
• Xi'an, China
• Zhengzhou, China
• Goyang-si, South Korea
• Seongnam-si, South Korea
• Seoul, South Korea
• Seoul, South Korea

Uygunluk kriterleri

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

Inclusion Criteria:

* Aged at least 18 years. Patient from Asia Pacific will be enrolled only.
* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
* Radiological documentation of disease progression on the last treatment administered prior to enrolling in the study: following 1st line EGFR TKI treatment but who have not received further treatment OR following prior therapy with an EGFR TKI and a platinum-based doublet chemotherapy. Patients may have also received additional lines of treatment.
* Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).
* Patients must have central confirmation of tumour T790M mutation positive status from a biopsy sample taken after confirmation of disease progression on the most recent treatment regimen.
* World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
* At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with computerised tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements.
* Females of child-bearing potential using contraception and must have a negative pregnancy test.

Exclusion Criteria:

* Treatment with an EGFR-TKI (eg, erlotinib, gefitinib, icotinib or afatinib) within 8 days or approximately 5x half-life of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; previous treatment with AZD9291 or a 3rd generation EGFR TKIs; Major surgery within 4 weeks of study entry; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of study entry; currently receiving treatment with potent inhibitors or inducers of CYP3A4.
* Any unresolved toxicities from prior therapy.
* Unstable spinal cord compression or brain metastases.
* Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or infection.
* Refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.
* Cardiac disease.
* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
* Inadequate bone marrow reserve or organ function.