Recruiting NCT07185997
Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Firmonertinib, EGFR-TKI inhibitor based on investigator's choice.
- Who it may be relevant to
- Registry conditions: Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer, EGFR P-Loop and Alpha C-Helix Compressing. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, France, Greece +11
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.
Interventions
- Drug Firmonertinib
240 mg oral, daily firmonertinib tablet - Drug EGFR-TKI inhibitor based on investigator's choice
osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet
Primary outcome measures
- Progression Free Survival (PFS) determined by blinded independent central review (BICR) [Time frame: Until progression or death, assessed up to approximately 4 years]
- Confirmed overall response rate (ORR) as determined by BICR [Time frame: Until progression or death, assessed up to approximately 3 years]
Secondary outcome measures (7)
- Overall survival (OS) [Time frame: Until death, assessed up to approximately 5 years]
- Investigator-assessed PFS [Time frame: Until progression or death, assessed up to approximately 4 years]
- Investigator-assessed confirmed ORR [Time frame: Until progression or death, assessed up to approximately 3 years]
- Duration of response (DOR) [Time frame: Until progression or death, assessed up to approximately 4 years]
- Time to second Progression-free survival (PFS2) [Time frame: Assessed up to approximately 5 years]
- Incidence and severity of adverse events (AEs), as a measure of safety and tolerability of firmonertinib [Time frame: Assessed up to approximately 5 years]
- Change from baseline in safety-related clinical laboratory test results [Time frame: Assessed up to approximately 5 years]
Eligibility criteria
Key Eligibility Criteria:
- Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.
- No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
- Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.
- Patients with asymptomatic CNS metastases are eligible.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- St. Jude Medical Center — Fullerton
- USC/Norris Comprehensive Cancer Center — Los Angeles
- Providence St. Joseph Hospital — Orange
- University of California Davis Comprehensive Cancer Center — Sacramento
- UCSF Medical Center-Mission Bay — San Francisco
- Kaiser Permanente Medical Center — Vallejo
- University of Colorado Health — Aurora
- Illinois Cancer Specialists — Arlington Heights
- … and 12 more centers
Japan · 11 centers
- Aichi Cancer Center — Nagoya
- National Cancer Center Hospital East — Kashiwa
- Kurume University Hospital — Kurume-Shi
- National Hospital Organization Hokkaido Cancer Center — Sapporo
- Hyogo Cancer Center — Akashi-shi
- Miyagi Cancer Center — Natori-shi
- Niigata Cancer Center Hospital — Niigata
- Kansai Medical University Hospital — Hirakata-shi
- … and 3 more centers
France · 7 centers
- Hospices Civil de Lyon — Bron
- Hospital Nord de Marseille — Marseille
- Centre Francois Baclesse — Caen
- Hopital Larrey — Toulouse
- Centre Leon-Berard — Lyon
- Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes — Saint-Herblain
- Insitut de Canderologie d I'Ouest — Saint-Herblain
South Korea · 7 centers
- The Catholic University of Korea, St. Vincent's Hospital — Suwon
- Chonnam National University Hwasun Hospital — Hwasun
- Gachon University Gil Medical Center — Incheon
- Kyung Hee University Hospital — Seoul
- Kangbuk Samsung Hospital — Seoul
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
Canada · 6 centers
- Alberta Health Services, Tom Baker Cancer Centre — Calgary
- BC Cancer Vancouver Centre — Vancouver
- Brampton Civic Hospital, William Osler Health Centre — Brampton
- The Ottawa Hospital Cancer Centre — Ottawa
- Sunnybrook Research Institute — Toronto
- Princess Margaret Cancer Centre - University Health Network — Toronto
Spain · 5 centers
- Hospital Universitari Son Espases — Palma
- Hospital Clinic de Barcelona — Barcelona
- Hospital QuironSalud Malaga — Málaga
- Hospital Universitario Central de Asturias — Oviedo
- Hospital Universitario y Politecnico La Fe — Valencia
Australia · 4 centers
- Blacktown Cancer and Haematology Centre — Blacktown
- Chris O'Brien Lifehouse — Camperdown
- GenesisCare North Shore Health Hub — St Leonards
- Austin Health — Heidelberg
Greece · 4 centers
- Henry Dunant Hospital Center — Athens
- University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA — Athens
- Athens Medical Center S.A., European Interbalkan Medical Center — Thessaloniki
- Thoracic General Hospital of Athens I Sotiria — Thessaloniki
Taiwan · 4 centers
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
- Taichung Veterans General Hospital — Taichung
- National Taiwan University Cancer Center — Taipei
- Taipei Veterans General Hospital — Taipei
Thailand · 4 centers
- Mahidol University - Siriraj Hospital — Bangkoknoi
- Chulabhorn Hospital — Lak Si
- Prince of Songkla Hospital — Hat Yai
- … and 1 more center
Turkey (Türkiye) · 4 centers
Center list to be confirmed — check the primary protocol.
Singapore · 3 centers
- National Cancer Centre Singapore — Singapore
- Curie Oncology (Farrer) — Singapore
- Tan Tok Seng Hospital — Singapore
United Kingdom · 3 centers
Center list to be confirmed — check the primary protocol.
Hong Kong · 2 centers
- Humanity and Health Clinical Trial Centre — Central
- Queen Mary Hospital — Hong Kong
Italy · 2 centers
- SOC Oncologia Medica e dei Tumori Immuno-correlati — Aviano
- Istituto Europeo di Oncologia (IEO) — Milan
Malaysia · 2 centers
- OncoCar Cancer Centre — Petaling Jaya
- Hospital Kuala Lumpur — Kuala Lumpur
Identifiers
NCT: NCT07185997 · FURMO-006