Furmonertinib for Non-Small Cell Lung Cancer

Not currently recruiting at 229 trial locations

Overseen By Vanessa Esquibel

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ArriVent BioPharma, Inc.

Must not be taking: EGFR-targeting agents

Disqualifiers: Prior systemic therapy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Until disease progression or unacceptable toxicity

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called furmonertinib for individuals with Non-Small Cell Lung Cancer (NSCLC) that has a mutation in the EGFR gene. It compares two doses of furmonertinib with standard platinum-based chemotherapy to determine which is more effective and safer. Participants should have advanced or metastatic NSCLC with a specific EGFR mutation and should not have received treatment for this cancer stage before. If participants had previous cancer treatments, a 12-month gap since the last treatment is required. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you have not received any prior systemic anticancer therapy for advanced or metastatic NSCLC, including EGFR-targeting agents.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that furmonertinib is generally safe for people with non-small cell lung cancer. One study found that 14.3% of patients experienced serious side effects, but these were manageable and did not require changing the dose or stopping the treatment. The treatment also demonstrated strong antitumor activity, effectively targeting cancer cells.

Another study reported that patients experienced improved quality of life with furmonertinib compared to gefitinib, indicating that patients generally felt better while taking furmonertinib. However, individual reactions can vary, and side effects may differ.

Overall, evidence suggests that furmonertinib is relatively safe for most patients, with controllable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about furmonertinib for non-small cell lung cancer because it offers a fresh approach compared to standard treatments like traditional platinum-based chemotherapies, such as cisplatin or carboplatin, often combined with pemetrexed. Furmonertinib is a targeted therapy that zeroes in on specific mutations in cancer cells, potentially leading to more effective treatment with fewer side effects. This precision targeting is what sets furmonertinib apart, aiming to improve patient outcomes by interfering directly with the cancer cell growth signals. Additionally, with its oral delivery method, furmonertinib offers a more convenient option compared to intravenous chemotherapy treatments.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that furmonertinib holds promise for treating non-small cell lung cancer (NSCLC) with certain gene mutations. In this trial, participants will receive either furmonertinib or platinum-based chemotherapy. Studies have demonstrated that patients taking a higher dose of 240 mg of furmonertinib had their cancer remain stable for about 16 months on average, meaning their cancer did not worsen during this period. At this dose, about 64% of patients experienced tumor shrinkage or disappearance. The 160 mg dose also proved effective, with about 76% of patients experiencing tumor shrinkage and 81% having their cancer remain stable for a year. These results suggest that furmonertinib could be an effective treatment option for this type of lung cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Morgan Lam

Principal Investigator

ArriVent BioPharm

Are You a Good Fit for This Trial?

This trial is for adults with advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that can't be removed by surgery or cured with radiotherapy. They must have a specific mutation in their cancer cells called EGFR exon 20 insertion and should not have had previous systemic anticancer treatments for advanced NSCLC, including any drugs targeting EGFR.

Inclusion Criteria

I haven't received any systemic anticancer treatments for my advanced NSCLC, including EGFR-targeting therapies.

I have had brain metastases treated or have new ones without symptoms.

My advanced lung cancer cannot be cured with surgery or radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either furmonertinib at 160 mg or 240 mg once daily, or platinum-based chemotherapy

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Furmonertinib
• Platinum-based Chemotherapy

Trial Overview The study compares two doses of a new oral drug, furmonertinib (160 mg and 240 mg daily), against standard platinum-based chemotherapy in patients who haven't been treated before for their lung cancer. Participants will be randomly assigned to one of the three treatment groups.

How Is the Trial Designed?

Group I: furmonertinib 240 mg Experimental Treatment 1 Intervention

furmonertinib tablet

Group II: furmonertinib 160 mg Experimental Treatment 1 Intervention

furmonertinib tablet

Group III: platinum-based chemotherapy Active Control 1 Intervention

carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously

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+

Allist Pharmaceuticals, Inc.

Industry Sponsor

Trials

24

Recruited

3,200+

Published Research Related to This Trial

In a study of 35 chemotherapy-naive patients with Stage IV nonsmall cell lung carcinoma (NSCLC), the combination of paclitaxel, cisplatin, and gemcitabine resulted in a high objective response rate of 73.5%, indicating strong efficacy for this treatment regimen.

The treatment was generally well tolerated, with manageable toxicity levels; however, significant side effects included Grade 3-4 neutropenia in 39.9% of patients, and there was one treatment-related death, highlighting the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel, cisplatin, and gemcitabine combination chemotherapy within a multidisciplinary therapeutic approach in metastatic nonsmall cell lung carcinoma. Rodriguez, J., Cortes, J., Calvo, E., et al.[2022]

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]

Five new cytotoxic drugs have been introduced for treating non-small-cell lung cancer (NSCLC), showing comparable activity to cisplatin when used alone, and improved survival when combined with cisplatin.

Randomized studies indicate that these newer drugs not only enhance survival rates but also reduce side effects compared to older chemotherapy regimens, suggesting they are valuable options for patients, including those previously treated with platinum-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for non-platinum chemotherapy in advanced NSCLC. Murren, JR.[2022]

Platinum-based chemotherapy has been shown to improve symptom control and provide small but significant improvements in progression-free and overall survival for patients with non-small cell lung cancer compared to best supportive care.

Combination chemotherapy using newer agents with cisplatin is now the standard treatment for advanced disease, offering better quality of life and survival, although it may increase the risk of hematological toxicity, especially in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy versus single agent chemotherapy in non-small cell lung cancer. Cheong, K., Spicer, J., Chowdhury, S., et al.[2019]

Furmonertinib, administered at 160 mg daily, showed promising efficacy in treating advanced non-small cell lung cancer (NSCLC) patients with brain metastases (BM) or leptomeningeal metastases (LM), achieving a median intracranial progression-free survival (iPFS) of 3.6 months for BM and 4.3 months for LM.

The treatment was generally well-tolerated, with 46.4% of patients experiencing adverse events, but only 14.3% had severe (grade 3 or higher) events, all of which were manageable without requiring dose reductions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial efficacy and safety of furmonertinib 160 mg with or without anti-angiogenic agent in advanced NSCLC patients with BM/LM as salvage therapy. Xu, Z., Hao, X., Wang, Q., et al.[2023]

Less than 25% of patients with non-small cell lung cancer (NSCLC) have early-stage disease that can be surgically removed, highlighting the need for effective treatments for advanced stages.

Cisplatin-based chemotherapy, especially in combination with newer agents like gemcitabine and paclitaxel, has shown improved survival rates and response rates exceeding 35% in advanced NSCLC, indicating its efficacy in managing this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on European randomized studies in non-small cell lung cancer. Giaccone, G., Manegold, C., Rosell, R., et al.[2007]

Cisplatin-based chemotherapy significantly improves survival and symptom control in stage IV non-small cell lung cancer patients with good performance status, suggesting its effectiveness as a primary treatment option.

Combination regimens including cisplatin and at least one other active drug (like ifosfamide or gemcitabine) are recommended, with four to six cycles proposed for patients who respond well, while non-platinum options can be considered for those unable to tolerate platinum-based treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stage IV NSCLC. Place of chemotherapy]. Meert, AP.[2013]

Recent advancements have led to the development of new drugs like irinotecan, paclitaxel, and docetaxel that show higher response rates in treating non-small cell lung cancer (NSCLC) compared to older treatments, which had a low overall response rate of only 15%.

Combination chemotherapy regimens using these newer agents have demonstrated promising efficacy in NSCLC, and ongoing randomized controlled trials are working to establish even more effective treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New chemotherapeutic agents for the treatment of non-small cell lung cancer: the Japanese experience. Saijo, N.[2019]

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 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 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]

In a study of 83 patients with advanced non-small cell lung cancer, a carboplatin and gemcitabine regimen resulted in a 43.4% overall response rate, indicating its effectiveness as a treatment option.

The regimen was well-tolerated across different age groups, with similar rates of severe side effects (grade 3-4 toxicity) in both elderly and non-elderly patients, suggesting it is a safe option for older patients as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine and carboplatin treatment in advanced NSCLC: a retrospective evaluation including elderly patients. Murialdo, R., Boy, D., Bertolotti, F., et al.[2022]

In patients with inoperable advanced non-small-cell lung cancer (NSCLC), new chemotherapy drugs like vinorelbine, gemcitabine, paclitaxel, and docetaxel, when combined with platinum-based therapies, have shown improved outcomes compared to older treatments.

For patients with good performance status, platin-based chemotherapy regimens that include these new drugs are recommended, while non-platin-based combinations are still considered investigational until proven effective in large trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New drugs in the palliative chemotherapy of advanced non-small-cell lung cancer. Malayeri, R., Pirker, R., Huber, H.[2017]

Citations

1. 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.

2. 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 ...

3. 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, ...

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 ... Conclusions: Furmonertinib has shown encouraging antitumor activity and CNS activity in patients with advanced NSCLC with EGFR ex20ins. Moreover ...

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

Efficacy and safety of furmonertinib in patients with EGFR ... The results indicated that 14.3% of these patients (n=4) who had grade ≥3 AEs experienced controlled outcomes with no dose reductions or therapeutic suspension ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05364073

NCT05364073 | Study of Furmonertinib in Patients With ... This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary ...