Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Activating EGFR or HER2 Mutations, Including Exon 20 Insertion Mutations

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b, open-label, multi-center, dose-escalation and dose-expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations, including Exon 20 insertion mutations. Patients will be enrolled into 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ArriVent BioPharma, Inc.
• Treatments: Aflutinib

Criteria

Key Inclusion Criteria:

• Histologically or cytologically documented, locally advanced or metastatic 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.

• Patients with a history of treated CNS metastases or new asymptomatic CNS metastases detected at screening are eligible.

• Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of the investigational product (furmonertinib).

• For patients with 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 Inclusion Criteria:

• 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.

• For patients with NSCLC with EGFR Exon 20 insertion mutations or HER2 Exon 20 insertion mutations, the patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.

• For patients with NSCLC with EGFR activating mutations other than Exon 20 insertion mutations, the patient must have experienced disease progression with the standard of care EGFR TKI.

Stage 2 Cohort 1 (Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations) Inclusion Criteria

• Documented validated results from either local testing of blood or tumor tissue confirming the presence of EGFR Exon 20 insertion mutations.

• The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.

Stage 2 Cohort 2 (Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations) Inclusion Criteria

• Documented validated results from either local testing of blood or tumor tissue confirming the presence of HER2 Exon 20 insertion mutations.

• The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.

Stage 2 Cohort 3 (Previously Treated NSCLC Patients with EGFR Activating Mutations and Excluding Exon 20 Insertion Mutations) Inclusion Criteria

• Documented validated results from either local testing of blood or tumor tissue confirming the presence of an EGFR activating mutation.

• The patient must have experienced disease progression or have intolerance to treatment with the standard of care EGFR TKI.

Key Exclusion Criteria:

• Treatment with chemotherapy, immunotherapy, biologic therapy or an investigational agent as anti-cancer therapy within 3 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 bony metastases within 2 weeks prior to initiation of furmonertinib.

• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia or Grade ≤ 2 peripheral neuropathy.