First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients With Central Nervous System (CNS) Metastases

Plain-language summary

This study investigates first-line treatment in patients with advanced non-small cell lung cancer carrying an EGFR mutation (L858R and/or Exon19Del) that has spread to the brain (central nervous system). The drugs AZD3759, Erlotinib and Gefitinib are examined; patients aged 18 and over who have not previously received chemotherapy or EGFR-TKI treatment for this cancer may take part. The study was conducted in Phase 2/Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE2/PHASE3

Status

Completed

Sponsor

Alpha Biopharma (Jiangsu) Co., Ltd.

Intervention

AZD3759, Erlotinib, Gefitinib

Start date

10/29/2018

Estimated completion

7/12/2022

Countries

China, Singapore, South Korea, Taiwan

Related genes

Locations

• 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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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.