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Non-small Cell Lung CancerPhase 2FOCUS-CNCT05334277

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

A Phase 2 study testing Furmonertinib, Furmonertinib/Pemetrexed/Carboplatin and Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 26 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Furmonertinib, Furmonertinib/Pemetrexed/Carboplatin and Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
26 sitesChina
Study dates
6 May 2022to 29 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • squamous cell lung carcinoma;
  • History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP);
  • Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis;
  • Patient who receive prior treatment including any of the following:
  • Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI);
  • The patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable;
Show all 25Show fewer
  • Major surgery within 4 weeks of the first dose of investigational product (IP);
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP;
  • CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period;
  • Traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period;
  • Patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period;
  • The time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer;
  • Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiation including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy before 6 months prior to the first dose;
  • At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy.
  • Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids.
  • Diagnosed other malignant tumors or had a history of other malignant tumors in last 5 years, except for skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ which have been effectively controlled;
  • Recent active digestive diseases such as duodenal ulcer, ulcerative colitis, ileitis, intestinal perforation, intestinal fistula, or other conditions that may cause gastrointestinal bleeding or perforation as the researchers may prescribe. Or refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of IP;
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, and active infection, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial;
  • Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease;
  • Any evidence of known corneal injury;
  • Inadequate bone marrow reserve or organ function;
  • QT prolongation or any clinically important abnormalities in rhythm or heart function;
  • Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators;
  • Pregnancy or lactation;
  • Patients who have had allogeneic bone marrow transplantation or received blood transfusion within 120 days prior to genetic sample collection.

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhang MD Li, 58 contact

13902282893

zhangli@sysucc.org.cn

Fang Wen Feng, 46 contact

15322302066

fangwf@sysucc.org.cn

26 sites in 1 country

China26 sites, 26 recruiting

  • The First Hospital of Jilin University

    Changchun

    Jiuwei Cui

    Jiuwei Cui

    Not yet recruiting

  • Sichuan Provincial People's Hospital

    Chengdu

    Haitao Lan

    Haitao Lan

    Not yet recruiting

  • Dongguan People's Hospital

    Dongguan

    Jun Jia

    Jun Jia

    Not yet recruiting

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

    Dongyang

    Xiaofang Dong

    Xiaofang Dong

    Not yet recruiting

  • The First People's Hospital of Foshan

    Foshan

    Hua Zhang

    Hua Zhang

    Not yet recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou

    Weidong Li

    Weidong Li

    Not yet recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou

    Laiyu Liu

    Laiyu Liu

    Not yet recruiting

  • Sun Yat-sen University cancer center

    Guangzhou

    Li Zhang, zhangli@sysucc.org.cn

    Wenfeng Fang, fangwf@sysucc.org.cn

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou

    Kejing Tang

    Kejing Tang

    Not yet recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

    Jianying Zhou

    Jianying Zhou

    Not yet recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

    Hong Shen

    Hong Shen

    Not yet recruiting

  • Zhejiang Provincial Hospital of Chinese Medicine

    Hangzhou

    Qijin Shu

    Qijin Shu

    Not yet recruiting

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

    Jiangmen

    Daren Lin

    Daren Lin

    Not yet recruiting

  • Affiliated Jinhua Hospital, Zhejiang University School of Medicine

    Jinhua

    Dan Zhu

    Dan Zhu

    Not yet recruiting

  • Mianyang Central Hospital

    Mianyang

    Xiaobo Du

    XIaobo Du

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Fei Xu

    Fei Xu

    Not yet recruiting

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

    Shenyang

    Jinghui Bai

    Jinghui Bai

    Not yet recruiting

  • Shijiazhuang People's hospital

    Shijiazhuang

    Yan Zhang

    Yan Zhang

    Not yet recruiting

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi

    Zhigang Han

    Zhigang Han

    Not yet recruiting

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

    Wenzhou

    Zongxiao Shangguan

    Zongxiao Shangguan

    Not yet recruiting

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

    Wuhan

    Rui Meng

    Rui Meng

    Not yet recruiting

  • Yijishan Hospital, Wannan Medical College

    Wuhu

    Zhiwei Lu

    Zhiwei Lu

    Not yet recruiting

  • Tangdu Hospital, Fourth Military Medical University

    Xi'an

    Faguang Jin

    Faguang Jin

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Yu Yao

    Yu Yao

    Not yet recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

    Zhengxiang Han

    Zhengxiang Han

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Hong Li

    Hongmin Wang

    Not yet recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This is a prospective, multicenter, randomized, open label, clinical study in China.

In total the study aims to screen 720 patients and enroll approximately 280 advanced NSCLC patients with EGFR mutation positive circulating tumor cell DNA, consisting of 47 patients whose ctDNA is cleared after 3 weeks furmonertinib will receive furmonertinib monotherapy, and approximately 233 patients with uncleared ctDNA after 3weeks furmonertinib monotherapy will receive furmonertinib alone or furmonertinib in combination with chemotherapy or furmonertinib in combination with chemotherapy and bevacizumab in the main trial. In the main part of the trial, for the approximately 233 patients with uncleared ctDNA, there are 2 / 2 / 1 in 5 chances of receiving furmonertinib alone, furmonertinib plus chemotherapy, or furmonertinib plus chemotherapy and bevacizumab. The treatment is decided at random by a computer.

The study involves a Screening Period, Induction treatment period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 9 visits. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study site.

Being tested
Furmonertinib, Furmonertinib/Pemetrexed/Carboplatin, Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab
Keywords
Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FurmonertinibDrug

    Also called AST2818

    Furmonertinib 80mg QD

  • FurmonertinibDrug

    Also called AST2818

    Furmonertinib 80mg QD

  • Furmonertinib/Pemetrexed/CarboplatinDrug

    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.

  • Furmonertinib/Pemetrexed/Carboplatin/BevacizumabDrug

    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.

Study groups in NCT05334277
Study groupRoleWhat they receive
Group A: Furmonertinib 80mg QDExperimentalFurmonertinib (AST2818) 80mg QD. All patients enrolled into this group will receive furmonertinib 80mg daily.
Receives: Drug: Furmonertinib
Group B1: Furmonertinib 80mg QDExperimentalFurmonertinib (AST2818) 80mg QD. All patients enrolled into this group will receive furmonertinib 80mg daily.
Receives: Drug: Furmonertinib
Group B2: Furmonertinib plus chemotherapyExperimentalFurmonertinib 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.
Receives: Drug: Furmonertinib/Pemetrexed/Carboplatin
Group B3: Furmonertinib plus chemotherapy and bevacizumabExperimentalFurmonertinib 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.
Receives: Drug: Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.

    Measured: The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 34 months after the first patient begin study treatment

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response

    Measured: Analysis will occur when PFS maturity is observed at approximately 34 months from the first patient begin study treatment

  2. Disease Control Rate (DCR)

    Disease control rate (DCR) is defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator.

    Measured: Analysis will occur when PFS maturity is observed at approximately 34 months from the first patient begin study treatment

  3. Duration of Response (DoR)

    Duration of Response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.

    Measured: Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 34 months from the first patient begin study treatment

  4. Overall Survival (OS)

    Overall survival is defined as the time from beginning of study treatment until death due to any cause.

    Measured: The analysis of OS will be conducted at 2 time points: when PFS maturity is observed at approximately 34 months after the first patient begin study treatment, and when OS maturity is observed at approximately 70 months after the first patient begin study

  5. Landmark Overall Survival (LOS)

    Landmark Overall Survival at 1, 3 and 5 years will look at the number of patients alive at 1-, 3- and 5-year time points.

    Measured: The analysis of Landmark Overall Survival will be conducted at 2 time points: when PFS maturity is observed at approximately 34 months after the first patient begin study treatment, and when Overall Survival maturity is observed at approximately 70 month

  6. Adverse Events

    The number of patients with adverse events and the severity according to CTCAE v5.0.

    Measured: From the start of study drug to 30 days after the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2022
  2. Study start6 May 2022
  3. Primary completion28 Feb 2025 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05334277
Sponsor's protocol ID
B2021-296-01
Acronym
FOCUS-C
Status last verified
Aug 2022
First submitted
7 Apr 2022
Last updated
31 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Furmonertinib, Furmonertinib/Pemetrexed/Carboplatin and Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 26 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhang MD Li, 58 (13902282893, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 34 months after the first patient begin study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05334277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.

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