Firmonertinib

Phase 3Small molecule

AAllist Pharmaceuticals, Inc.

Firmonertinib is one of 175 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

174

Competitors

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerRecruiting

MetastasisActive, not recruiting

NSCLC (non-Small Cell Lung Carcinoma)Recruiting

NSCLCRecruiting

Advanced NSCLCNot yet recruiting

Leptomeningeal MetastasesRecruiting

Non-Small Cell Lung CancerPhase 3

Recruiting

MetastasisPreclinical

Active, not recruiting

NSCLC (non-Small Cell Lung Carcinoma)Phase 2

Recruiting

NSCLCPhase 3

Recruiting

Advanced NSCLCPhase 2

Not yet recruiting

Leptomeningeal MetastasesPhase 3

Recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Femara

Novartis

Phase 3

1 2

Apatinib

LLaNova Medicines Zhejiang Co., Ltd.

Phase 3

13 3

AK104

AAkeso

Phase 3

6 4

Firmonertinib

AAllist Pharmaceuticals, Inc.

Phase 3

2 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Post-ApprovalRecruiting

Leptomeningeal Metastases

NCT07092202

Q4 2030

Phase 3Recruiting

Non-Small Cell Lung Cancer

NCT07185997

Phase 2Recruiting

NSCLC (non-Small Cell Lung Carcinoma)

NCT07314216

Q2 2031

Phase 2Not yet recruiting

Non-Small Cell Lung Cancer

NCT07661173

Q2 2032

Phase 3Recruiting

NSCLC

NCT07010419

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)

Recruiting·AArriVent BioPharma, Inc.·Phase 3·NCT07185997·480 enrolled

A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer

Not yet recruiting·AAnhui Provincial Cancer Hospital·Phase 2·NCT07661173·154 enrolled

Leptomeningeal Metastases1 trial

Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Mutant NSCLC With Leptomeningeal Metastases

Recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 4·NCT07092202·40 enrolled

Metastasis1 trial

Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis

Completed·—··NCT07239102·300 enrolled

Advanced NSCLC1 trial

Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg

Not yet recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT07298148·28 enrolled

NSCLC1 trial

A Global Phase 3, Double-Blind, Randomized, Controlled Multicenter Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy (FIRMOST)

Recruiting·AAllist Pharmaceuticals, Inc.·Phase 3·NCT07010419·338 enrolled

1 more indication

NSCLC (Non-small Cell Lung Carcinoma)1 trial

A Single-Arm, Multicenter, Phase II Clinical Trial of Firmonertinib in Combination With Definitive Radiotherapy for Patients With Stage III Unresectable Pulmonary Adenocarcinoma Harboring Positive EGFR Uncommon Driver Mutations

Recruiting·HHunan Cancer Hospital·Phase 2·NCT07314216·15 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Firmonertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Firmonertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Firmonertinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Allist Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAllist Pharmaceuticals, Inc.

Firmonertinib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q4 2030

Q2 2031

Q2 2032

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

Leptomeningeal Metastases1 trial

Metastasis1 trial

Advanced NSCLC1 trial

NSCLC1 trial

NSCLC (Non-small Cell Lung Carcinoma)1 trial

References

Drug Info

Quick Facts

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