FURMO-002: This study is evaluating how safe and effective targeted therapy is in people with advanced or metastatic non-small cell lung cancer with activating EGFR or HER2 mutationsA 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

Summary

This study is recruiting people 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. Eligible participants will be assigned into one of two stages: Stage 1 (Dose escalation and Backfill Cohorts) and Stage 2 (Dose Expansion). In Stage 1 (Dose Escalation and Backfill), participants will receive escalating doses of Furmonertinib (a type of targeted therapy) which will be given as an oral tablet. In Stage 2 (Dose Expansion), participants will be grouped into cohorts depending on their diagnosis. All participants will receive Furmonertinib as an oral tablet. Stage 2 Cohort 1 will enrol people with previously treated NSCLC with EGFR Exon 20 Insertion Mutations. Stage 2 Cohort 2 will enrol people with previously treated NSCLC with HER2 Exon 20 Insertion Mutations. Stage 2 Cohort 3 will enrol people with previously treated NSCLC with EGFR Activating Mutations who are not eligible for Cohorts 1 and 4. Stage 2 Cohort 4 will enrol people with either untreated or previously treated EGFR TKI Naïve NSCLC with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations.

Treatment Type

Systemic therapy (chemotherapy, hormone therapy or immunotherapy)