What is the mechanism of action of this treatment?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, chemotherapy, and immunotherapy. Targeted therapies, such as EGFR inhibitors like Furmonertinib, work by blocking the epidermal growth factor receptor (EGFR) pathway, which is often mutated in NSCLC and promotes cancer cell growth and survival. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while immunotherapy, such as PD-1/PD-L1 inhibitors, enhances the body's immune response against cancer cells. These mechanisms are crucial for NSCLC patients as they offer personalized treatment options that can improve outcomes and reduce side effects compared to traditional therapies.

What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that are similar to Furmonertinib, such as Almonertinib and Gefitinib, are known to have several side effects. Almonertinib can cause interstitial lung disease (ILD), presenting as chest tightness, shortness of breath, and dry cough. Gefitinib is generally well tolerated but can lead to skin toxicities in 71% of patients, including severe skin toxicities in some cases, and mild to moderate diarrhea in 50% of patients. These side effects are important considerations when choosing an appropriate treatment plan.

What prior FDA approvals exist?

Several EGFR inhibitors have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). These include gefitinib, erlotinib, and osimertinib, which target specific mutations in the EGFR gene. These drugs are used primarily in patients with advanced or metastatic NSCLC harboring EGFR mutations. Furmonertinib, currently under investigation, is another EGFR inhibitor showing promise in clinical trials for similar patient populations.

What other types of research exist?

Promising alternatives to Furmonertinib for NSCLC patients include: 1) Alectinib, which has shown efficacy in ALK-positive NSCLC, 2) Brigatinib, effective in crizotinib-refractory ALK-positive NSCLC, 3) Lorlatinib, another option for ALK-positive NSCLC, 4) Pyrotinib, targeting HER2 mutations, and 5) Sotorasib, for KRASG12C mutations. These alternatives have demonstrated significant efficacy in recent clinical trials.

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Tyrosine Kinase Inhibitor

Furmonertinib for Non-Small Cell Lung Cancer

Phase 3

Recruiting

Research Sponsored by ArriVent BioPharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically documented, locally advanced or metastatic non-squamous NSCLC not amenable to curative surgery or radiotherapy.

No prior systemic anticancer therapy regimens received for locally advanced or metastatic NSCLC including prior treatment with any EGFR-targeting agents (e.g., previous EGFR TKIs, monoclonal antibodies, or bispecific antibodies).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization up to ≤30 days after last dose

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing furmonertinib at two different doses to treat a specific type of lung cancer. It targets patients with advanced or metastatic non-squamous NSCLC who have a particular genetic mutation. The medication works by blocking a protein that helps cancer cells grow, potentially slowing down or stopping the cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from furmonertinib may include diarrhea, rash, dry skin, nail changes, mouth sores, decreased appetite, vomiting and liver enzyme elevations. Platinum-based chemotherapy can cause nausea, hair loss, fatigue and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I haven't had cancer treatment for at least 12 months.

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

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My lung cancer cannot be cured with surgery or radiotherapy.

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My cancer has a specific EGFR mutation.

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I had treatment for cancer that hadn't spread, with no treatments in the last year.

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My tests show an EGFR exon 20 mutation in my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization up to ≤30 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization up to ≤30 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to ≤30 days after last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)

Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)

Malignant Neoplasms

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: furmonertinib 240 mgExperimental Treatment1 Intervention

furmonertinib tablet

Group II: furmonertinib 160 mgExperimental Treatment1 Intervention

furmonertinib tablet

Group III: platinum-based chemotherapyActive Control1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, chemotherapy, and immunotherapy. Targeted therapies, such as EGFR inhibitors like Furmonertinib, work by blocking the epidermal growth factor receptor (EGFR) pathway, which is often mutated in NSCLC and promotes cancer cell growth and survival. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while immunotherapy, such as PD-1/PD-L1 inhibitors, enhances the body's immune response against cancer cells. These mechanisms are crucial for NSCLC patients as they offer personalized treatment options that can improve outcomes and reduce side effects compared to traditional therapies.

New targeted treatments in lung cancer--overview of clinical trials.