EGFR Mutasyonu Pozitif, Merkezi Sinir Sistemi (central nervous system) Metastazlı İleri Evre Küçük Hücreli Dışı Akciğer Kanserinde (non-small cell lung cancer) Birinci Basamak Tedavi

Sade dilde özet

Bu çalışma, EGFR mutasyonu (L858R ve/veya Exon19Del) taşıyan ve beyne, yani merkezi sinir sistemine (central nervous system) yayılmış ileri evre küçük hücreli dışı akciğer kanseri (non-small cell lung cancer) olan hastalarda birinci basamak tedaviyi araştırıyor. AZD3759, Erlotinib ve Gefitinib adlı ilaçlar inceleniyor; daha önce bu kanser için kemoterapi veya EGFR-TKI tedavisi almamış, 18 yaş ve üzeri hastalar katılabiliyor. Çalışma Faz 2/Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

PHASE2/PHASE3

Durum

Tamamlandı

Sponsor

Alpha Biopharma (Jiangsu) Co., Ltd.

Müdahale

AZD3759, Erlotinib, Gefitinib

Başlangıç

29.10.2018

Tahmini bitiş

12.07.2022

Ülkeler

China, Singapore, South Korea, Taiwan

İlgili genler

Merkezler

• Hefei, China
• Chongqing, China
• Fuzhou, China
• Xiamen, China
• Guangzhou, China
• Guangzhou, China
• Haerbin, China
• Zhengzhou, China
• Zhengzhou, China
• Wuhan, China
• Wuhan, China
• Wuhan, China
• Yichang, China
• Changsha, China
• Nanjing, China
• Nanjing, China
• Suzhou, China
• Wuxi, China
• Xuzhou, China
• Yangzhou, China
• Changchun, China
• Changchun, China
• Xi'an, China
• Jinan, China
• Linyi, China
• Weifang, China
• Yantai, China
• Chengdu, China
• Kunming, China
• Hangzhou, China
• Hangzhou, China
• Hangzhou, China
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Chongqing, China
• Chongqing, China
• Shanghai, China
• Shanghai, China

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Uygunluk kriterleri

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

Inclusion Criteria:

1. Properly completed patient informed consent
2. Male or female aged at least 18 years
3. Histologically or cytologically confirmed diagnosis of NSCLC with activating EGFR mutations including L858R and/or Exon19Del. EGFR mutation status will be determined by local or central laboratory testing on tumour tissue or plasma utilizing a validated methodology which has been approved by the regulatory authority.
4. No prior treatment with chemotherapy, EGFR-TKIs, or biological therapies that are considered first line treatment for advanced NSCLC.
5. All patients must have a documented diagnosis of advanced (Stage IV) NSCLC with Magnetic Resonance Imaging (MRI) documented CNS metastases that include brain metastases (BM). BM + patients with co- existent leptomeningeal involvement are eligible for the study.
6. Eligible patients are not candidates for definitive surgical resection or radiation of all lesions in the opinion of the treating physician.
7. All patients must be stable without any systemic (oral or parenteral) corticosteroid or anticonvulsant therapy for at least 2 weeks prior to study treatment. Inhaled non-absorbable and topical corticosteroid use are permitted as indicated.
8. Patients may have prior placement of a properly functioning CNS shunt or Ommaya reservoir.
9. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 with no deterioration over the previous 2 weeks.
10. Women of child-bearing potential and male subjects shall agree to take medically acceptable contraception measures while on study treatment and for 3 months following completion of study treatment. All women of child-bearing potential must have a negative blood pregnancy test at screening.
11. (a) For Patients with measurable CNS lesions must have AT LEAST ONE site of CNS lesion, which was not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter by MRI and which is suitable for accurate repeated measurements. Measurable extracranial disease is not required. (b) For Patients with non-measurable CNS lesions must have AT LEAST ONE extracranial lesion, which has not been previously irradiated, within the screening period that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) by CT/MRI and are suitable for accurate repeated measurement.