Furmonertinib for Non-Small Cell Lung Cancer

Not currently recruiting at 57 trial locations

Overseen By Nichole Baio

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ArriVent BioPharma, Inc.

Must be taking: Osimertinib

Must not be taking: Chemotherapy, Targeted therapy

Disqualifiers: Recent cancer therapy, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, furmonertinib, for safety and effectiveness in people with advanced or metastatic non-small cell lung cancer (NSCLC). The focus is on patients with specific mutations, such as those affecting the EGFR or HER2 genes, which drive cancer growth. The trial includes different groups, including those who have not responded to other treatments. Suitable participants have lung cancer that has worsened after other treatments and have specific mutations confirmed by a test. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires that you stop taking chemotherapy, targeted therapy, biologic therapy, or investigational agents as anti-cancer therapy within 3 weeks or 3 elimination weeks (whichever is shorter) before starting furmonertinib. Endocrine therapy must be stopped 2 weeks prior, and radiation therapy must be stopped 4 weeks prior, except for palliative radiation to bone metastases, which must be stopped 2 weeks prior.

Is there any evidence suggesting that furmonertinib is likely to be safe for humans?

Research shows that furmonertinib is generally well-tolerated by patients with advanced non-small cell lung cancer (NSCLC). In earlier studies, furmonertinib demonstrated promising results in shrinking tumors while maintaining a good safety record. For example, patients with certain changes in the EGFR gene experienced positive results with manageable side effects. Furmonertinib has also received approval in China for some types of lung cancer, indicating it has passed safety checks for those uses. However, as this trial is in its early stages, researchers are still closely studying the treatment for safety. Participants might experience some side effects, but researchers are carefully monitoring these. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

Furmonertinib is unique because it specifically targets EGFR and HER2 mutations found in non-small cell lung cancer (NSCLC), which are not always addressed by standard treatments like osimertinib or afatinib. Unlike these existing options, which primarily target common EGFR mutations, furmonertinib aims to tackle uncommon mutations, including those involving exon 20 insertions. This focus on a broader range of mutations offers new hope for patients who haven't responded well to other therapies. Researchers are excited about furmonertinib because it expands the reach of targeted therapies, potentially offering a more personalized and effective treatment for hard-to-treat cases of NSCLC.

What evidence suggests that furmonertinib might be an effective treatment for non-small cell lung cancer?

Research has shown that furmonertinib may help treat non-small cell lung cancer (NSCLC) in people with certain gene changes. This trial will explore furmonertinib's effectiveness across various treatment arms. Studies have found that furmonertinib works well against cancer cells with changes in the EGFR gene. In one study, 63.6% of patients responded to the treatment. Another study showed a 75.8% response rate and an 87.9% rate of controlling the disease, significantly slowing cancer growth. These findings suggest that furmonertinib could be a strong treatment option for NSCLC patients with specific genetic profiles. ^{3 4 6 7 8}

Who Is on the Research Team?

Morgan Lam

Principal Investigator

ArriVent BioPharma

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic NSCLC who have specific EGFR or HER2 mutations. They must have progressed after standard therapy, including osimertinib if applicable, and may have treated brain metastases. Those ineligible include patients with recent cancer therapies, active malignancies within the last 5 years (except certain skin cancers), or those living outside the US.

Inclusion Criteria

I may have cancer spread to my brain but meet specific criteria for the study.

My tests show a specific mutation in my cancer (EGFR or HER2).

My tests show a specific mutation in my cancer.

Exclusion Criteria

I haven't had cancer treatment within the last 3 weeks or less before starting furmonertinib.

I have a history of cancer.

I have received radiation for bone cancer within the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Stage 1 involves dose escalation and backfill cohorts to evaluate safety and pharmacokinetics

8-12 weeks

Dose Expansion

Stage 2 involves dose expansion to further evaluate safety and antitumor activity in specific patient cohorts

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Furmonertinib

Trial Overview The study tests Furmonertinib's safety and effectiveness in two stages: dose escalation to find a safe dosage and dose expansion to further assess its impact on lung cancer with certain genetic changes. It's an early-phase trial for patients whose cancer has worsened despite previous treatments.

How Is the Trial Designed?

Group I: Stage 2 Expansion Cohort 4 Experimental Treatment 1 Intervention

Untreated or Previously treated EGFR TKI Naïve NSCLC Patients with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations

Group II: Stage 2 Expansion Cohort 3 Experimental Treatment 1 Intervention

Previously treated NSCLC Patients with EGFR Activating Mutations, who are not eligible for Cohorts 1 and 4

Group III: Stage 2 Expansion Cohort 2 Experimental Treatment 1 Intervention

Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations

Group IV: Stage 2 Expansion Cohort 1 Experimental Treatment 1 Intervention

Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations

Group V: Stage 1 Dose Escalation and Backfill Experimental Treatment 1 Intervention

Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations

Furmonertinib is already approved in China for the following indications:

Approved in China as Furmonertinib for:

• Non-Small Cell Lung Cancer (NSCLC) with EGFR mutations

Who Is Running the Clinical Trial?

ArriVent BioPharma, Inc.

Lead Sponsor

Trials

2

Recruited

550+

Published Research Related to This Trial

Furmonertinib demonstrated a high objective response rate of 74% in patients with EGFR T790M mutated advanced non-small-cell lung cancer, indicating strong efficacy as a treatment option after first or second generation EGFR TKIs.

The safety profile of furmonertinib was acceptable, with 26% of patients experiencing grade 3 or higher adverse events, but most were manageable and included common issues like increased liver enzymes and mild gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. Shi, Y., Hu, X., Zhang, S., et al.[2021]

Furmonertinib demonstrated significantly better efficacy than gefitinib in treating EGFR mutation-positive non-small-cell lung cancer, with a median progression-free survival of 20.8 months compared to 11.1 months for gefitinib, based on a study involving 358 patients.

The safety profile of furmonertinib was acceptable, with fewer grade 3 or higher treatment-related adverse events (11%) compared to gefitinib (18%), indicating it may be a safer first-line treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Furmonertinib (AST2818) versus gefitinib as first-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer (FURLONG): a multicentre, double-blind, randomised phase 3 study. Shi, Y., Chen, G., Wang, X., et al.[2022]

Furmonertinib is a selective EGFR tyrosine kinase inhibitor approved in China for treating patients with advanced non-small cell lung cancer (NSCLC) who have the EGFR T790M mutation and have progressed after previous EGFR TKI therapy.

The drug is currently being evaluated in ongoing phase I/II and phase III trials for various EGFR mutations in NSCLC, indicating its potential for broader application in lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Furmonertinib: First Approval. Deeks, ED.[2022]

Furmonertinib demonstrated promising efficacy in treating advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertions, achieving an objective response rate (ORR) of 37.7% and a disease control rate (DCR) of 92.5% among 53 patients studied.

The treatment showed a favorable safety profile, with the most common adverse events being diarrhea and rash, but no severe (grade ≥3) treatment-related adverse events were reported, indicating that furmonertinib is well-tolerated across different dosage groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A real-world study of the efficacy and safety of furmonertinib for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations. Sa, H., Shi, Y., Ding, C., et al.[2023]

Citations

1. thelancet.com thelancet.com/journals/lanwpc/article/PIIS2666-6065(24)00116-0/fulltext

Patient-reported outcomes for the phase 3 FURLONG ... In this study, furmonertinib provided improvements compared with gefitinib in PRO profile, with statistically better mean score changes from baseline up to, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10917975/

The efficacy of furmonertinib in untreated advanced ... Furmonertinib is more effective at inhibiting tumor cells with these mutations compared to cells with the normal, wild-type EGFR.

3. ir.arrivent.com ir.arrivent.com/news-releases/news-release-details/arrivent-presents-final-analysis-firmonertinib-monotherapy-data

Release Details 16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line ...

4. iaslc.org iaslc.org/iaslc-news/press-release/results-further-trial-demonstrate-firmonertinib-promising-potential

Results from the FURTHER Trial Demonstrate ... The confirmed overall response rates were 63.6% (n=22; 95% CI, 40.7%-82.8%; with 1 unconfirmed partial response pending confirmation) at the 240 ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)04747-1/fulltext

658P Furmonertinib 160mg as first-line treatment for ... Preliminary efficacy results: ORR was 75.8% (95%CI, 57.70% to 88.9%), DCR was 87.9% (95%CI, 71.8% to 96.6%), one-year PFS rate was 81% assessed by the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37004599/

A real-world study of the efficacy and safety ... Furmonertinib has shown encouraging antitumor activity and CNS activity in patients with advanced NSCLC with EGFR ex20ins.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05364073

NCT05364073 | Study of Furmonertinib in Patients With ... Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer ... safety and tolerability of Furmonertinib, Up to 36 months ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12076557/

Efficacy and safety of furmonertinib in patients with EGFR ... To explore efficacy and safety of furmonertinib, the present retrospective study analyzed patients with EGFR-mutant advanced lung adenocarcinoma (LUAD) who ...