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Clinical Trials List

Protocol NumberFURMO-006

NCT Number(ClinicalTrials.gov Identfier)NCT07185997

Not yet recruiting

2025-12-08 - 2030-12-31

Phase III

Not yet recruiting1

Recruiting1

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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)

Trial Applicant

Pharmaceutical Research Associates Taiwan Inc.
Sponsor

ArriVent BioPharma, Inc.
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Jen-Yu Hung

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator James Chih-Hsin Yang 無

National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small-Cell Lung Cancer

Objectives

Primary Objective To evaluate the antitumor activity of firmonertinib compared with investigator’s choice of osimertinib or afatinib in participants with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR PACC mutations. Secondary Objectives • To further evaluate the antitumor activity of firmonertinib compared with investigator’s choice of osimertinib or afatinib in participants with locally advanced or metastatic NSCLC harboring EGFR PACC mutations. • To evaluate the safety and tolerability of firmonertinib compared with investigator’s choice of osimertinib or afatinib in participants with locally advanced or metastatic NSCLC harboring EGFR PACC mutations.

Test Drug

tablet

Active Ingredient

Firmonertinib

Dosage Form

110

Dosage

40 mg

Endpoints

Progression-Free Survival (PFS) as determined by Blinded Independent Central Review (BICR).

Confirmed Overall Response Rate (ORR) as determined by Blinded Independent Central Review (BICR).

Inclution Criteria

• Histologically or cytologically confirmed locally advanced or metastatic non–small cell lung cancer (NSCLC) that is not amenable to curative surgery or radiotherapy.
• Presence of epidermal growth factor receptor (EGFR) PACC mutation in tumor tissue or plasma, as confirmed by local testing.
• No prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC, including any previous EGFR-targeted therapy (e.g., prior EGFR tyrosine kinase inhibitors [TKIs], monoclonal antibodies, or bispecific antibodies).
• Participants who previously received neoadjuvant and/or adjuvant chemotherapy, immunotherapy, or chemoradiotherapy for non-metastatic disease must have a treatment-free interval of at least 12 months.
• Participants with asymptomatic central nervous system (CNS) metastases are eligible.

Exclusion Criteria

NSCLC harboring any of the following EGFR mutations: exon 19 deletion, L858R, or C797S.

Prior treatment with any EGFR-targeted therapy (e.g., EGFR tyrosine kinase inhibitor [EGFR-TKI], proteolysis-targeting chimera [PROTAC] directed against EGFR, monoclonal antibody, or bispecific antibody).

Prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy, including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.

History of interstitial lung disease (ILD), including drug-induced ILD, or active ILD/radiation pneumonitis.

Mean baseline corrected QT interval (QTc) > 470 ms, as determined by the average of three electrocardiograms (ECGs) corrected using Fridericia’s formula (QTcF).

The Estimated Number of Participants

Taiwan

16 participants
Global

480 participants