Advanced or Metastatic Non-small Cell Lung CancerPhase 3NCT06674343
Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations
A Phase 3 study testing Furmonertinib in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Furmonertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 31 Dec 2028
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old, Male or Female
- Histologically or cytologically confirmed locally advanced or metastatic lung adenocarcinoma not amenable to curative surgery or radiotherapy;
- Patients have been confirmed by local laboratory to have one of the following EGFR mutations: 19Del or L858R (single or compound)
- Patients had locally advanced NSCLC or metastatic NSCLC without any systemic antitumor therapy
- Having at least one measurable lesion (in accordance with RECIST1.1). Note: measurable lesion can neither be subject to local therapy as radiotherapy nor used for biopsy in screening period; if there is only one measurable lesion, this lesion will be permitted to be biopsied. However, the baseline radiological examination can be performed for this lesion at least 14 days after biopsy
- Adequate organ function as shown in the laboratory test, including: (1) ANC >= 1.5 x 10^9/L; PLT >= 100 x 10^9/L; HGB >= 90 g/L; (2) TBIL <= 1.5 times ULN, AST and ALT <= 2.5 times ULN (with liver metastasis, TBIL <= 3 times ULN, AST and ALT <= 5 times ULN); (3) CrCL >= 50 mL/min (according to Cockcroft-Gault formula);
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- ECOG PS 0-1, and there was no obvious disease deterioration within 2 weeks prior to screening
- Life expectancy > 12 weeks after the first dose of investigational product
- Female of childbearing age are not pregnant and have no pregnancy plan. Female subjects at childbearing age and male subjects agree to take effective contraceptive measures during the study and within 6 months after drug discontinuation
- Being able to understand and voluntarily participate in the study, and sign the informed consent form.
Who cannot join
- NSCLC with predominant squamous cell histology, small cell lung cancer or neuroendocrine carcinoma indicated by histology or cytology test
- Patients with other driver oncogenes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation, but not TP53, RB1, BRAC mutation, etc.);
- Expected to receive other anti-tumor therapy other than the investigational product during the study
- Having received the following therapies: (1) Having been irradiated for > 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;
- Concurrent spinal cord compression or symptomatic brain metastasis
- The toxicity caused by previous anti-tumor therapy has not recovered to <= CTCAE grade 1 (CTCAE 5.0) (except alopecia, sequelae of previous platinum-related neurotoxicity) or the level specified in the inclusion/exclusion criteria;
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- Unstable pleural effusion or peritoneal effusion with obvious symptoms; those with stable clinical symptoms for at least 14 days after drainage of pleural effusion or ascites will be eligible
- Having a history of other malignant tumor, or other concurrent malignant tumors (except those that have undergone radical operation and have no recurrence within 5 years post operation, e.g. cervical carcinoma in situ, basal cell carcinoma of skin and papillary thyroid carcinoma)
- Previous interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected interstitial lung disease
- Having severe or uncontrolled systemic disease requiring treatment that is considered by investigators as ineligible for the study, including hypertension, diabetes, chronic heart failure (NYHA Functional Classification III-IV), unstable angina pectoris, myocardial infarction within one year, active hemorrhagic disease, etc.
- QTc > 470 ms on ECG at resting state
- Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval; for example, complete left bundle branch block, degree III atrioventricular block, congenital long QT syndrome, serious hypokalemia, or current use of drugs that may lead to prolonged QT interval
- Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product
- Infectious disease requiring intravenous medication
- Known history of mental disease or drug abuse, and currently having an attack or still taking drugs
- Known or suspected allergy to Furmonertinib or other components of its preparation
- Female subjects or female partners of male subjects who are pregnant or lactating, or plan to be pregnant during the study
- Poor compliance, inability to comply with the study procedures, restriction or requirements
- Other conditions that are considered by investigators as unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yan C Xu, 01069155154, maraxu@163.com
About this study
Official title: The Efficacy and Safety of Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With EGFR Classical Mutations, a Prospective, Single-arm, Multicenter Clinical Study
To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).
Read the detailed description
To evaluate the PFS, ORR, DCR, OS, CNS ORR CNS DCR, CNS PFS, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).
- Being tested
- Furmonertinib
- Keywords
- advanced or metastatic non-small cell lung cancer, EGFR mutation
- 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
Furmonertinib 160mg, once daily, orally. Other Names: AST2818
| Study group | Role | What they receive |
|---|---|---|
| Furmonertinib | Experimental | Furmonertinib 160mg, once daily, orally Receives: Drug: Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Freae Survival (PFS)
The time from the first dose of the study drugs to the progression of the disease or death for any reason according to RECIST 1.1 by investigator
Measured: Approximately 24 months after the first patient begin study treatment
Secondary outcomes (7)
Objective Response Rate (ORR)
Rate of subjects whose tumors are assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
Measured: Approximately 12 weeks after the last patient begin study treatment
Disease Control Rate (DCR)
Rate of subjects whose tumors are assessed as CR, PR or stable disease (SD) according to RECIST 1.1
Measured: Approximately 12 weeks after the last patient begin study treatment
Overall survival (OS)
The time from the first dose of the study drugs to the death for any reason according to RECIST 1.1
Measured: Approximately 24 months after the last patient begin study treatment
Central Nervous System Objective Response Rate (CNS ORR)
Rate of subjects whose CNS tumors are assessed as complete response(CR) or partial response(PR) according to RECIST 1.1
Measured: Approximately 12 weeks after the last patient begin study treatment
Central Nervous System Disease Control Rate (CNS DCR)
Rate of subjects whose CNS tumors are assessed as CR, PR or stable disease (SD) according to RECIST 1.1
Measured: Approximately 12 weeks after the last patient begin study treatment
Central Nervous System Progression Free Survival (CNS PFS)
The time from the first dose of the study drugs to the progression of the CNS disease or death for any reason according to RECIST 1.1
Measured: Approximately 24 months after the first patient begin study treatment
Adverse Events (AEs)
The number of patients with adverse events and the severity according to CTCAE v5.0
Measured: From the start of study drug to 28 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.
- First posted5 Nov 2024
- Study start15 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674343
- Sponsor's protocol ID
- I-24PJ1180
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With EGFR Classical Mutations, a Prospective, Single-arm, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06674343
- Acronym / sponsor ID
- I-24PJ1180
- Keywords
- advanced or metastatic non-small cell lung cancer, EGFR mutation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).
Detailed description
To evaluate the PFS, ORR, DCR, OS, CNS ORR CNS DCR, CNS PFS, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furmonertinib | Experimental | Drug: FurmonertinibFurmonertinib 160mg, once daily, orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 years old, Male or Female
- Histologically or cytologically confirmed locally advanced or metastatic lung adenocarcinoma not amenable to curative surgery or radiotherapy;
- Patients have been confirmed by local laboratory to have one of the following EGFR mutations: 19Del or L858R (single or compound)
- Patients had locally advanced NSCLC or metastatic NSCLC without any systemic antitumor therapy
- Having at least one measurable lesion (in accordance with RECIST1.1). Note: measurable lesion can neither be subject to local therapy as radiotherapy nor used for biopsy in screening period; if there is only one measurable lesion, this lesion will be permitted to be biopsied. However, the baseline radiological examination can be performed for this lesion at least 14 days after biopsy
Key exclusion criteria (19 listed)
- NSCLC with predominant squamous cell histology, small cell lung cancer or neuroendocrine carcinoma indicated by histology or cytology test
- Patients with other driver oncogenes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation, but not TP53, RB1, BRAC mutation, etc.);
- Expected to receive other anti-tumor therapy other than the investigational product during the study
- Having received the following therapies: (1) Having been irradiated for > 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;
- Concurrent spinal cord compression or symptomatic brain metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurmonertinibFurmonertinib 160mg, once daily, orally. Other Names: AST2818 | Drug | Furmonertinib |
Primary outcome
Progression Freae Survival (PFS)
Time frame: Approximately 24 months after the first patient begin study treatment
The time from the first dose of the study drugs to the progression of the disease or death for any reason according to RECIST 1.1 by investigator
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Approximately 12 weeks after the last patient begin study treatment
Disease Control Rate (DCR)
Time frame: Approximately 12 weeks after the last patient begin study treatment
Overall survival (OS)
Time frame: Approximately 24 months after the last patient begin study treatment
Central Nervous System Objective Response Rate (CNS ORR)
Time frame: Approximately 12 weeks after the last patient begin study treatment
Central Nervous System Disease Control Rate (CNS DCR)
Time frame: Approximately 12 weeks after the last patient begin study treatment
Central Nervous System Progression Free Survival (CNS PFS)
Time frame: Approximately 24 months after the first patient begin study treatment
Adverse Events (AEs)
Time frame: From the start of study drug to 28 days after the last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furmonertinib in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site 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 10 inclusion and 19 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Freae Survival (PFS) (time frame: Approximately 24 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?
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 5 Nov 2024.