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New hope for Hard-to-Treat lung cancer: targeted drug shows promise in early trial

NCT ID NCT05364073

Disease control Sponsor: ArriVent BioPharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called furmonertinib in about 160 people with advanced or spreading non-small cell lung cancer that has certain gene changes (EGFR or HER2 mutations). The goal is to see if the drug is safe and can shrink tumors. Participants must have already tried other treatments without success.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

160 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. * Disease that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable; or for whom a clinical trial of an investigational agent is a recognized standard of care. * Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of furmonertinib. * For patients with Epidermal Growth Factor Receptor (EGFR) mutations sensitive to osimertinib, the patient must have received osimertinib prior to study enrollment in regions where osimertinib is approved, including the US. Stage 1 dose escalation and backfill cohorts and Stage 2 Cohorts 1, 2, 3 and 4: -Patients with CNS metastases (including leptomeningeal disease) may be eligible if meeting additional protocol specified criteria. Stage 1 Dose Escalation and Backfill Cohorts Inclusion Criteria: \- 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. Stage 2 Cohort 1 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Exon 20 Insertion Mutations Inclusion Criteria * Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory. * The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy. Stage 2 Cohort 2 Previously treated, Locally Advanced or Metastatic NSCLC Patients with HER2 Exon 20 Insertion Mutations Inclusion Criteria * Documented validated results from local testing of either tumor tissue or blood confirming the presence of HER2 Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory. * The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy. * In regions in which fam-trastuzumab deruxtecan-nxki is approved and available for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 exon 20 mutations, the patient must have received or be considered not appropriate to receive fam-trastuzumab deruxtecan-nxki. Stage 2 Cohort 3 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Activating Mutations Mutations, who are not eligible for Cohorts 1 and 4 Inclusion Criteria * Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR activating mutation, performed at a CLIA- or equivalently certified laboratory. * The patient must have experienced disease progression or have intolerance to treatment with the standard of care EGFR TKI. * Patients with CNS metastases may be eligible if meeting additional protocol specified criteria. Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations excluding EGFR Exon 20 insertions Inclusion Criteria * Previously untreated in the locally advanced or metastatic setting or have progressed after at least 1 available standard therapy, or for whom standard therapy has proven to be ineffective, intolerable, or considered inappropriate * Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR Uncommon mutation, performed at a CLIA- or equivalently certified laboratory a. Representative mutations include, but are not limited to, G719X, S768I, E709X, G779F, L747X, V774M, E709\_T710delinsD, R776C/H, G724S, E736K, I740\_K745dup, N771G, K757M/R, V769L/M, T854X, T751\_I759delinsN Key Exclusion Criteria: * Treatment with chemotherapy, targeted therapy, biologic therapy or an investigational agent as anti-cancer therapy within 3 or 3 elimination weeks or five half-lives prior to initiation of furmonertinib, whichever is shorter, or endocrine therapy within 2 weeks prior to initiation of furmonertinib. * Radiation therapy as cancer therapy within 4 weeks prior to initiation of furmonertinib. * Palliative radiation to bone metastases within 2 weeks prior to initiation of furmonertinib. * AE from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia or Grade ≤ 2 peripheral neuropathy. Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations Exclusion Criteria * Prior treatment with any EGFR TKIs * Progression during neoadjuvant or adjuvant therapy (e.g., chemotherapy, radiotherapy, immunotherapy or investigational agents) or within 12 months of completion of above therapies.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced non-small cell lung cancer EGFR exon 20 mutations EGFR uncommon mutations, including G719X and S768I HER2 exon 20 mutations Metastatic non-small cell lung cancer Non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

  • Allist Investigative Site

    Hefei, Anhui, 230001, China

  • Allist Investigative Site

    Beijing, Beijing Municipality, 101119, China

  • Allist Investigative Site

    Chaoyang, Beijing Municipality, 100021, China

  • Allist Investigative Site

    Chongqing, Chongqing Municipality, 400030, China

  • Allist Investigative Site

    Harbin, Heilongjiang, 150081, China

  • Allist Investigative Site

    Zhengzhou, Henan, 450003, China

  • Allist Investigative Site

    Zhengzhou, Henan, 450052, China

  • Allist Investigative Site

    Wuhan, Hubei, 430022, China

  • Allist Investigative Site

    Xuzhou, Jiangsu, 221000, China

  • Allist Investigative Site

    Nanchang, Jianxi, 330008, China

  • Allist Investigative Site

    Changchun, Jilin, 130012, China

  • Allist Investigative Site

    Jinan, Shandong, 250021, China

  • Allist Investigative Site

    Jinan, Shandong, 250117, China

  • Allist Investigative Site

    Taiyuan, Shanxi, 030013, China

  • ArriVent Investigative Site

    Prescott, Arizona, 86301, United States

  • ArriVent Investigative Site

    Sacramento, California, 95817, United States

  • ArriVent Investigative Site

    Whittier, California, 90603, United States

  • ArriVent Investigative Site

    Celebration, Florida, 34747, United States

  • ArriVent Investigative Site

    Detroit, Michigan, 48202, United States

  • ArriVent Investigative Site

    Houston, Texas, 77030, United States

  • ArriVent Investigative Site

    Fairfax, Virginia, 22031, United States

  • ArriVent Investigative Site

    Blacktown, New South Wales, 2148, Australia

  • ArriVent Investigative Site

    St Leonards, New South Wales, 2065, Australia

  • ArriVent Investigative Site

    Heidelberg, Victoria, 3084, Australia

  • ArriVent Investigative Site

    Lyon, 69373, France

  • ArriVent Investigative Site

    Medolla, 47014, Italy

  • ArriVent Investigative Site

    Chiba, Chiba, 260-0013, Japan

  • ArriVent Investigative Site

    Barcelona, 08035, Spain

  • ArriVent Investigative Site

    Madrid, 28033, Spain

  • ArriVent Investigative Site

    Madrid, 28050, Spain

  • ArriVent Investigative Site

    Valencia, 46026, Spain

  • ArriVent Investigative Site

    London, NW12PG, United Kingdom

  • Arrivent Investigative Site

    Edmonton, T6G 1Z2, Canada

  • Arrivent Investigative Site

    Toronto, M5G 2M9, Canada

  • Arrivent Investigative Site

    Toulouse, 31059, France

  • Arrivent Investigative Site

    Villejuif, 94800, France

  • Arrivent Investigative Site

    Ōsaka-sayama, Osaka, 589-8511, Japan

  • Arrivent Investigative Site

    Chūō, Tokyo, 104-0045, Japan

  • Arrivent Investigative Site

    Koto-Ku, Tokyo, 135-8550, Japan

  • Arrivent Investigative Site

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Arrivent Investigative Site

    Gwangju, 61469, South Korea

  • Arrivent Investigative Site

    Seoul, 2447, South Korea

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