FurmOnertinib Mesylate With or Without Chemotherapy +/- bevacizUmab as firSt Line Treatment in Advanced Non-small Cell Lung Cancer Patients With Uncleared Epidermal Growth Factor Receptor (EGFR) Mutation Positive Circulating Tumor Cell DNA

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

EGFR mutation positive advanced NSCLC patients with uncleared ctDNA have poor prognosis, whether they can benefit from combination therapy has not been reported. This study aims to investigate the efficacy and safety of combination therapy compared with furmonertinib monotherapy in advanced EGFR mutant NSCLC with uncleared circulating tumor cell DNA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Provide informed consent prior to any study specific procedures;

• at least 18 years of age;

• ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy ≥12 weeks;

• Pathologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC);

• Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy;

• Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically and confirmed by ctDNA, the reports must be issued or recognized by Tier 3A hospitals. The mutations above may exist alone or together;

• Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy;

• According to RECIST 1.1, patients have at least one tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline;

• For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;

⁃ Willing to use contraception as appropriate during the study and for a period after discontinuing study treatment;

⁃ Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment;

⁃ Voluntary and agree to sign the informed consent for genetic research, and provide enough fresh blood samples for central NGS testing.

Locations
Other Locations
China
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Dongguan People's Hospital
NOT_YET_RECRUITING
Dongguan
Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang People's hospital
NOT_YET_RECRUITING
Dongyang
The First People's Hospital of Foshan
NOT_YET_RECRUITING
Foshan
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University cancer center
RECRUITING
Guangzhou
The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Zhejiang Provincial Hospital of Chinese Medicine
NOT_YET_RECRUITING
Hangzhou
Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Sun Yat-sen University
NOT_YET_RECRUITING
Jiangmen
Affiliated Jinhua Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Jinhua
Mianyang Central Hospital
NOT_YET_RECRUITING
Mianyang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITING
Shenyang
Shijiazhuang People's hospital
NOT_YET_RECRUITING
Shijiazhuang
The Affiliated Cancer Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
The Third Affiliated Hospital of Wenzhou Medical University, Rui'an People's Hospital
NOT_YET_RECRUITING
Wenzhou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Yijishan Hospital, Wannan Medical College
NOT_YET_RECRUITING
Wuhu
Tangdu Hospital, Fourth Military Medical University
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Zhang MD Li, 58
zhangli@sysucc.org.cn
13902282893
Backup
Fang Wen Feng, 46
fangwf@sysucc.org.cn
15322302066
Time Frame
Start Date: 2022-05-06
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 280
Treatments
Experimental: Group A: Furmonertinib 80mg QD
Furmonertinib (AST2818) 80mg QD. All patients enrolled into this group will receive furmonertinib 80mg daily.
Experimental: Group B1: Furmonertinib 80mg QD
Furmonertinib (AST2818) 80mg QD. All patients enrolled into this group will receive furmonertinib 80mg daily.
Experimental: Group B2: Furmonertinib plus chemotherapy
Furmonertinib 80 mg QD and platinum-based chemotherapy All patients enrolled into this group will receive furmonertinib 80 mg daily, in combination with Pemetrexed (500 mg/m2) plus carboplatin (AUC 5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) every 3 weeks.
Experimental: Group B3: Furmonertinib plus chemotherapy and bevacizumab
Furmonertinib 80 mg QD plus platinum-based chemotherapy and bevacizumab All patients enrolled into this group will receive furmonertinib 80 mg daily, in combination with Pemetrexed (500 mg/m2) plus carboplatin (AUC 5) plus bevacizumab (7.5mg/kg) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed (500 mg/m2) with bevacizumab (7.5mg/kg) maintenance every 3 weeks.
Sponsors
Collaborators: Allist Pharmaceuticals, Inc., GeneCast Biotechnology Co., Ltd.
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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