Lung AdenocarcinomaPhase 2NCT04965831
Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)
A Phase 2 study testing Furmonertinib in people with Lung Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Furmonertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 May 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study.
- Primary lung adenocarcinoma diagnosed histologically/cytologically.
- Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators.
- EGFR mutation positive (19Del or L858R, with or without T790M)
- The presence of at least one measurable lesion and suitable for accurate repeated measurements.
- ECOG performance status 0-1.
- For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.
Who cannot join
- Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma.
- Patients with EGFR exon 20 insertion mutation.
- Exposure to other antitumor therapies prior to enrolment.
- Major surgery was performed in the four weeks prior to the first dosing of the study drug.
- Pregnant or lactating female patients.
- Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration.
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- Have a history of or present complications with other malignancies.
- Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study.
- ECG QT interval prolongation or associated risk.
- A history of interstitial pneumonia or related risk.
- Inadequate bone marrow or organ reserve.
- Other circumstances that are not suitable for participation in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Furmonertinib Mesylate as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable, EGFR Sensitizing Mutation Positive Lung Adenocarcinoma Patients: A Phase II, Single-arm, Open-label Clinical Study (FRONT)
This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.
Read the detailed description
Please refer to detailed description in the following context.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Furmonertinib
- Medical subject headings
- Adenocarcinoma of 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/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Furmonertinib | Experimental | Furmonertinib as perioperation therapy Receives: Drug: Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1
Measured: Approximately 8 weeks following the first dose of study drug
Secondary outcomes (4)
Disease Control Rate (DCR)
Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1
Measured: Approximately 8 weeks following the first dose of study drug
Progression free survival (PFS)
The time from the first does of the study drugs to the progression of the disease or death for any reason.
Measured: Approximately 3 years following the first dose of study drug
Disease free survival (DFS)
The time from the end of surgery to the progression of the disease or death for any reason.
Measured: Approximately 3 years following the first dose of study drug
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 posted16 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Allist Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Changli Wang, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965831
- Sponsor's protocol ID
- AST-PMR2003
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD sharing plan is not to be shared according to the policy.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furmonertinib Mesylate as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable, EGFR Sensitizing Mutation Positive Lung Adenocarcinoma Patients: A Phase II, Single-arm, Open-label Clinical Study (FRONT)
- ClinicalTrials.gov ID
- NCT04965831
- Acronym / sponsor ID
- AST-PMR2003
- Conditions
- Lung Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Allist Pharmaceuticals, Inc.
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Jul 2021 (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.
This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.
Detailed description
Please refer to detailed description in the following context.
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 as perioperation therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study.
- Primary lung adenocarcinoma diagnosed histologically/cytologically.
- Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators.
- EGFR mutation positive (19Del or L858R, with or without T790M)
- The presence of at least one measurable lesion and suitable for accurate repeated measurements.
Key exclusion criteria (12 listed)
- Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma.
- Patients with EGFR exon 20 insertion mutation.
- Exposure to other antitumor therapies prior to enrolment.
- Major surgery was performed in the four weeks prior to the first dosing of the study drug.
- Pregnant or lactating female patients.
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 |
|---|---|---|
| FurmonertinibAlso: AST2818Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery. | Drug | Furmonertinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: Approximately 8 weeks following the first dose of study drug
Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: Approximately 8 weeks following the first dose of study drug
Progression free survival (PFS)
Time frame: Approximately 3 years following the first dose of study drug
Disease free survival (DFS)
Time frame: Approximately 3 years following the first dose of study drug
Adverse Events (AEs)
Time frame: From the start of study drug to 28 days after the last dose of study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: No. The IPD sharing plan is not to be shared according to the policy.
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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.
Changli Wang, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furmonertinib in people with Lung Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
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 7 inclusion and 12 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 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Changli Wang, MD (+86 022-23340123, aswindcc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Approximately 8 weeks following the first dose of study drug). 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 16 Jul 2021.