ClinConnect ClinConnect Logo
Search / Trial NCT03653546

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

Central Nervous System Metastases Respiratory Tract Diseases Egfr Exon 19 Del L858 R Lung Neoplasm Carcinoma, Non Small Cell Lung Neoplasms

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.

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

0 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

Similar Trials