RecruitingPhase 2NCT05334277

Furmonertinib Monotherapy and Combination Therapy in Advanced EGFR Mutant NSCLC With Uncleared ctDNA

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

Sponsor

Sun Yat-sen University

Enrollment

280 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether furmonertinib — a targeted therapy drug — alone or in combination with other treatments can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC) driven by specific EGFR gene mutations, particularly in patients whose cancer DNA is still detectable in the blood after diagnosis. **You may be eligible if...** - You are 18 or older with non-squamous NSCLC that is locally advanced or metastatic - Your tumor has an EGFR mutation (exon 19 deletion or L858R), confirmed by blood (ctDNA) testing - You have not received prior treatment for advanced NSCLC - You have measurable tumor lesions and good overall health **You may NOT be eligible if...** - You have squamous cell lung cancer - You have an EGFR exon 20 insertion mutation - You have previously received any EGFR-targeted therapy - You are pregnant or breastfeeding - You have a history of interstitial lung disease (ILD) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFurmonertinib

Furmonertinib 80mg QD

DRUGFurmonertinib

Furmonertinib 80mg QD

DRUGFurmonertinib/Pemetrexed/Carboplatin

Furmonertinib 80mg daily + 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.

DRUGFurmonertinib/Pemetrexed/Carboplatin/Bevacizumab

Furmonertinib 80mg daily + 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.

Locations(26)

The First Hospital of Jilin University

Changchun, China

Sichuan Provincial People's Hospital

Chengdu, China

Dongguan People's Hospital

Dongguan, China

Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang People's hospital

Dongyang, China

The First People's Hospital of Foshan

Foshan, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, China

Nanfang Hospital, Southern Medical University

Guangzhou, China

Sun Yat-sen University cancer center

Guangzhou, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Provincial Hospital of Chinese Medicine

Hangzhou, China

Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Sun Yat-sen University

Jiangmen, China

Affiliated Jinhua Hospital, Zhejiang University School of Medicine

Jinhua, China

Mianyang Central Hospital

Mianyang, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute

Shenyang, China

Shijiazhuang People's hospital

Shijiazhuang, China

The Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, China

The Third Affiliated Hospital of Wenzhou Medical University, Rui'an People's Hospital

Wenzhou, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Yijishan Hospital, Wannan Medical College

Wuhu, China

Tangdu Hospital, Fourth Military Medical University

Xi'an, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT05334277

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