Non-Small-Cell Lung CancerPhase 2NCT05255406
Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)
A Phase 2 study testing Furmonertinib (160mg) in people with Non-Small-Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Furmonertinib (160mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2021to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female subjects aged ≥18 years old;
- Locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology (stage ⅢB-Ⅳ, according to the 8th Edition of the AJCC Staging system);
- The tumour harbours one of the most common EGFR mutations (19del or L858R);
- The programmed death-ligand 1 (PD-L1) tumoral expression is positive;
- No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
- According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline;
- ECOG performance status score 0-2；
- Subjects have voluntarily participated, signed and dated informed consent.
Who cannot join
- Lung squamous carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma) and small cell lung cancer;
- Subjects have no measurable tumor lesion at baseline;
- Subjects with spinal cord compression or symptomatic brain metastases;
- Subjects are suitable for surgery;
- Previous therapy with platinum-based chemotherapy, EGFR-TKIs, or anti-PD1/PD-L1 agents;
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 × ULN, or serum total bilirubin (TBIL)>1.5 × ULN, or Cr>1.0×ULN;
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- Absolute value of neutrophil (ANC)<1.5 × 109/L, or platelet (PLT) count<75 × 109/L, or hemoglobin (HGB)<90 g/L;
- Any of the following disease within 12 months: myocardial infarction, severe/unstable stenocardia, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident;
- Women who are pregnancy or lactation, or fertile but not using contraception;
- Suffering from other serious acute or chronic physical or mental problems;
- Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Hui Yu, MD, +86 13801725650, yhui30@hotmail.com
About this study
Official title: A Prospective, Single-arm, Phase 2 Clinical Trial of Furmonertinib as the First-line Treatment in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC
The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Furmonertinib (160mg)
- 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.
Furmonertinib (160mg)Drug
Also called AST2818
160mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (80mg).
| Study group | Role | What they receive |
|---|---|---|
| Furmonertinib | Experimental | Furmonertinib (160mg) Receives: Drug: Furmonertinib (160mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year Progression Free Survival Rate
Percentage of subjects still alive and progression free one year after inclusion in the study.
Measured: One year after inclusion
Secondary outcomes (4)
One-year Overall Survival Rate
Percentage of subjects still alive one year after inclusion in the study.
Measured: one year after inclusion
Progression Free Survival
The time from the first does of the study drugs to the progression of the disease or death for any reason.
Measured: Approximately 2 years following the first dose of study drugs
Objective Response Rate
Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
Measured: Approximately 2 years following the first dose of study drugs
Adverse Events
Number of participants with adverse events as a measure of safety and tolerability.
Measured: Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start9 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Allist Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Huiyu, Fudan University
- Investigators
- Hui Yu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255406
- Sponsor's protocol ID
- FMTN-IIT-2021-001
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Phase 2 Clinical Trial of Furmonertinib as the First-line Treatment in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT05255406
- Acronym / sponsor ID
- FMTN-IIT-2021-001
- Conditions
- Non-Small-Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Allist Pharmaceuticals, Inc.
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Feb 2022 (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.
The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC.
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: Furmonertinib (160mg)Furmonertinib (160mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged ≥18 years old;
- Locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology (stage ⅢB-Ⅳ, according to the 8th Edition of the AJCC Staging system);
- The tumour harbours one of the most common EGFR mutations (19del or L858R);
- The programmed death-ligand 1 (PD-L1) tumoral expression is positive;
- No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
Key exclusion criteria (11 listed)
- Lung squamous carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma) and small cell lung cancer;
- Subjects have no measurable tumor lesion at baseline;
- Subjects with spinal cord compression or symptomatic brain metastases;
- Subjects are suitable for surgery;
- Previous therapy with platinum-based chemotherapy, EGFR-TKIs, or anti-PD1/PD-L1 agents;
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 |
|---|---|---|
| Furmonertinib (160mg)Also: AST2818160mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (80mg). | Drug | Furmonertinib |
Primary outcome
One-year Progression Free Survival Rate
Time frame: One year after inclusion
Percentage of subjects still alive and progression free one year after inclusion in the study.
4 secondary outcomes
One-year Overall Survival Rate
Time frame: one year after inclusion
Progression Free Survival
Time frame: Approximately 2 years following the first dose of study drugs
Objective Response Rate
Time frame: Approximately 2 years following the first dose of study drugs
Adverse Events
Time frame: Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hui Yu, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furmonertinib (160mg) in people with Non-Small-Cell Lung Cancer, run by Fudan University 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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 4 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Yu, MD (+86 13801725650, yhui30@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year Progression Free Survival Rate (time frame: One year after inclusion). 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 4 Aug 2022.