What is the mechanism of action of this treatment?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies such as Tyrosine Kinase Inhibitors (TKIs) that focus on specific genetic mutations like EGFR and HER2. These inhibitors, including drugs like Furmonertinib, work by blocking the tyrosine kinase enzymes involved in the signaling pathways that promote cancer cell growth and survival. By inhibiting these pathways, TKIs can effectively reduce tumor growth and proliferation. This is particularly important for NSCLC patients with these specific mutations, as it allows for a more personalized and effective treatment approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common side effects of EGFR and HER2 Tyrosine Kinase Inhibitors (TKIs) used in the treatment of Non-Small Cell Lung Cancer (NSCLC) include diarrhea, rashes, anorexia, and anemia. Specifically, for Furmonertinib, reported side effects include diarrhea, rashes, hypermagnesemia, and pericardial effusion. Serious adverse events, though less common, can also occur and may include severe diarrhea and skin reactions.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) target EGFR and HER2 mutations. For EGFR mutations, osimertinib is a notable tyrosine kinase inhibitor (TKI) approved for first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. For HER2 mutations, fam-trastuzumab deruxtecan is approved for patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations and who have received prior systemic therapy. These treatments are similar to Furmonertinib, which is being studied for its efficacy in patients with advanced or metastatic NSCLC with EGFR or HER2 mutations.

What other types of research exist?

Promising alternatives to Furmonertinib for NSCLC patients include Capmatinib and Tepotinib for MET exon-14-skipping mutations, Pembrolizumab plus Lenvatinib for advanced cases not amenable to curative surgery or radiation, and selective RET inhibitors like Selpercatinib and Pralsetinib for RET-altered tumors. These agents have demonstrated significant efficacy in clinical trials and are viable options for treatment in 2024.

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Tyrosine Kinase Inhibitor

Furmonertinib for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by ArriVent BioPharma, Inc.

Eligibility Criteria Checklist

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

Must have

Documented validated results from local testing of blood or tumor tissue confirming the presence of an EGFR Exon 20 insertion mutation, HER2 Exon 20 insertion mutation, or EGFR activating mutation.

Documented validated results from local testing of tumor tissue or blood confirming the presence of an activating, including uncommon, EGFR mutation or HER2 exon 20 insertion mutation performed at a CLIA-or equivalently certified laboratory

Must not have

History of active malignancy

Palliative radiation to bone metastases within 2 weeks prior to initiation of furmonertinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, side effects of Furmonertinib could include typical reactions to cancer drugs such as nausea, fatigue, liver issues, rash or other skin problems. The exact side effects will be monitored closely given this is an early-stage trial.

Eligibility Criteria

Inclusion Criteria

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

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

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My tests show a specific mutation in my cancer.

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My tests show an uncommon EGFR mutation in my cancer.

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My cancer has worsened after my last cancer treatment.

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My lung cancer cannot be cured with surgery or radiation.

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I have taken osimertinib for my EGFR-mutant cancer, as it's approved in my region.

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I have taken osimertinib for my EGFR-mutant cancer, as it's approved in my region.

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My lung cancer cannot be cured with surgery or radiation.

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My condition worsened after treatment, or treatments didn't work or caused severe side effects.

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My cancer has worsened after my last cancer treatment.

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My cancer got worse or I couldn't tolerate platinum-based chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cancer.

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

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My cancer got worse during or within 12 months after finishing initial treatments.

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I have had a condition where my lymphocytes grow abnormally.

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I have been treated with EGFR inhibitors before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Stage 2 Expansion Cohort 4Experimental Treatment1 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 3Experimental Treatment1 Intervention

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

Group III: Stage 2 Expansion Cohort 2Experimental Treatment1 Intervention

Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations

Group IV: Stage 2 Expansion Cohort 1Experimental Treatment1 Intervention

Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations

Group V: Stage 1 Dose Escalation and BackfillExperimental Treatment1 Intervention

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

0 / 16Eligibility 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 such as Tyrosine Kinase Inhibitors (TKIs) that focus on specific genetic mutations like EGFR and HER2. These inhibitors, including drugs like Furmonertinib, work by blocking the tyrosine kinase enzymes involved in the signaling pathways that promote cancer cell growth and survival. By inhibiting these pathways, TKIs can effectively reduce tumor growth and proliferation. This is particularly important for NSCLC patients with these specific mutations, as it allows for a more personalized and effective treatment approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Chronic exposure to cigarette smoke leads to activation of p21 (RAC1)-activated kinase 6 (PAK6) in non-small cell lung cancer cells.Tailoring tyrosine kinase inhibitors to fit the lung cancer genome.New targeted treatments in lung cancer--overview of clinical trials.