NCT04858958: FAVOUR

Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation

Active, enrolled Phase 1 Last updated 19 November 2025

What this trial tests

Phase 1 trial testing Furmonertinib 160mg in NSCLC in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 August 2020

Primary endpoint
5 December 2024

28 February 2026

Quick facts

Lead sponsor	Allist Pharmaceuticals, Inc.
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	10 August 2020
Primary completion	5 December 2024
Estimated completion	28 February 2026
Sites	1 location across China

Drugs / interventions tested

• Furmonertinib 160mg — full drug profile →
• Furmonertinib 240mg — full drug profile →

Conditions studied

• NSCLC — all drugs for NSCLC →

Sponsor

Allist Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase Ⅰb multi-center clinical study. To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation.

The study plans to enroll 30 subjects, including 20 treated patients and 10 treatment-naïve patients. The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mg/day (N=10) or 240 mg/day (N=10), respectively. The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mg/day (N=10) until disease progression, death or intolerability.

The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).

In addition, the peripheral blood ctDNA will be collected and analyzed in this study

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Structural Insight and Development of EGFR Tyrosine Kinase Inhibitors.
   Amelia T, Kartasasmita RE, Ohwada T, Tjahjono DH. · · 2022 · cited 83× · PMID 35164092 · DOI 10.3390/molecules27030819
2. EGFR exon 20 insertion mutations in advanced non-small-cell lung cancer: current status and perspectives.
   Hou J, Li H, Ma S, He Z, et al · · 2022 · cited 44× · PMID 35418149 · DOI 10.1186/s40364-022-00372-6
3. Spotlight on Furmonertinib (Alflutinib, AST2818). The Swiss Army Knife (del19, L858R, T790M, Exon 20 Insertions, "uncommon-G719X, S768I, L861Q") Among the Third-Generation EGFR TKIs?
   Zhang SS, Ou SI. · · 2022 · cited 22× · PMID 36317157 · DOI 10.2147/lctt.s385437
4. Novel therapeutic strategies for rare mutations in non-small cell lung cancer.
   Gou Q, Gou Q, Gan X, Xie Y. · · 2024 · cited 21× · PMID 38705930 · DOI 10.1038/s41598-024-61087-2
5. A real-world study of the efficacy and safety of furmonertinib for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations.
   Sa H, Shi Y, Ding C, Ma K. · · 2023 · cited 21× · PMID 37004599 · DOI 10.1007/s00432-023-04726-x
6. Advances in the management of non-small-cell lung cancer harbouring <i>EGFR</i> exon 20 insertion mutations.
   Low JL, Lim SM, Lee JB, Cho BC, et al · · 2023 · cited 17× · PMID 36756143 · DOI 10.1177/17588359221146131
7. Furmonertinib for EGFR-mutant advanced non-small cell lung cancer: a glittering diamond in the rough of EGFR-TKI.
   Ding J, Ding X, Zeng J, Liu X. · · 2024 · cited 10× · PMID 38440180 · DOI 10.3389/fphar.2024.1357913
8. Case Report: A good response to furmonertinib second-line treatment of an advanced lung adenocarcinoma patient with a rare EGFR exon 20 N771_P772insH mutation: A case report and literature review.
   Zhang X, Han H, Zhao J, Liu X, et al · · 2022 · cited 7× · PMID 36059942 · DOI 10.3389/fphar.2022.964606