Furmonertinib for Non-Small Cell Lung Cancer

Recruiting at 52 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

170 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing furmonertinib, a medication for advanced lung cancer patients with specific genetic mutations. It aims to see if the drug can block signals that make cancer cells grow, potentially slowing down or stopping the cancer. Furmonertinib was recently approved in China for treating patients with advanced lung cancer with confirmed genetic mutations.

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.

What data supports the effectiveness of the drug Furmonertinib for non-small cell lung cancer?

Furmonertinib has shown effectiveness in treating non-small cell lung cancer (NSCLC) with specific genetic mutations, such as EGFR T790M and exon 20 insertions, in several studies. It has been approved in China for patients whose cancer has progressed after previous treatments, and it has demonstrated positive results in both real-world and clinical trial settings. ^{1 2 3 4 5}

What makes the drug Furmonertinib unique for treating non-small cell lung cancer?

Furmonertinib is a third-generation drug that specifically targets certain mutations in the cancer cells, including the T790M mutation, which makes it effective even when other treatments have stopped working. It can also penetrate the brain, making it useful for patients whose cancer has spread to the central nervous system. ^{1 2 3 4 5}

Research Team

Morgan Lam

Principal Investigator

ArriVent BioPharma

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Furmonertinib: First Approval. [2022]

2. Germany 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. [2023]

3. England 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. [2021]

4. England 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Central nervous system efficacy of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small cell lung cancer: a pooled analysis from two phase 2 studies. [2023]