Informations générales (source: ClinicalTrials.gov)
A Phase 1b Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
Interventional
Phase 1
ArriVent BioPharma, Inc. (Voir sur ClinicalTrials)
juin 2022
septembre 2025
02 mai 2025
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 non-small cell lung
cancer (NSCLC) with activating, including uncommon, Epidermal Growth Factor Receptor
(EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be
enrolled into one of 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2
(Dose Expansion).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 17/05/2024 12:56:29 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Arrivent Investigative Site - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| ArriVent Investigative Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Arrivent Investigative Site - 94800 - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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.