First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients with Central Nervous System (CNS) Metastases
Launched by ALPHA BIOPHARMA (JIANGSU) CO., LTD. · Aug 28, 2018
Trial Information
Current as of May 08, 2025
Completed
Keywords
ClinConnect Summary
This is a Phase II/III randomized, open-label, multicenter study to compare the efficacy and safety of first line single-agent AZD3759 vs. Erlotinib or Gefitinib treatment in patients with advanced EGFR mutation positive NSCLC with CNS metastases.
Eligible patients with documented EGFR mutation+ (L858R and/or Exon 19Del) TKI-naïve advanced NSCLC and documented intracranial disease will be enrolled.
Gender
ALL
Eligibility criteria
- 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.
About Alpha Biopharma (Jiangsu) Co., Ltd.
Alpha Biopharma (Jiangsu) Co., Ltd. is a leading biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapeutic solutions. With a strong focus on advancing healthcare, the company specializes in the creation of novel drug candidates aimed at addressing unmet medical needs across various therapeutic areas. Leveraging cutting-edge technology and a robust pipeline, Alpha Biopharma is committed to enhancing patient outcomes through rigorous clinical trials and strategic partnerships, positioning itself as a key player in the global biopharmaceutical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hefei, Anhui, China
Fuzhou, Fujian, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Haerbin, Heilongjiang, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Yichang, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Suzhou, Jiangsu, China
Wuxi, Jiangsu, China
Xuzhou, Jiangsu, China
Yangzhou, Jiangsu, China
Changchun, Jilin, China
Xi'an, Shaanxi, China
Jinan, Shandong, China
Linyi, Shandong, China
Weifang, Shandong, China
Yantai, Shandong, China
Chengdu, Sichuan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Beijing, , China
Chongqing, , China
Shanghai, , China
Tianjin, , China
Chungbuk, , Korea, Republic Of
Daegu, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Gyeongsang, , Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Ulsan, , Korea, Republic Of
Singapore, , Singapore
Taichung, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Changchun, Jilin, China
Patients applied
Trial Officials
Yilong Wu, M.D.
Study Chair
Guangdong Provincial People's Hospital
Myung-Ju Ahn, M.D.
Principal Investigator
Samsung Medical Center, Sungkyunkwan University School of Medicine
Jie Wang, M.D.
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Qing Zhou, M.D.
Principal Investigator
Guangdong Provincial People's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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