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RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well firmonertinib works and how safe it is compared with osimertinib or afatinib. It is for people with non-small cell lung cancer that has spread nearby or to other parts of the body, has certain EGFR gene changes called PACC mutations, and has not been treated for advanced disease. People are assigned by chance to take one of these medicines daily.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-small cell lung cancer confirmed by a tissue or cell test.
  • The cancer has spread nearby or to other parts of the body and cannot be cured with surgery or radiation.
  • A tumor or blood test shows one of the EGFR PACC gene changes listed as eligible for this study.
  • Have not had cancer medicines for advanced lung cancer, including medicines that target EGFR.
  • If you had chemotherapy, immune treatment, or chemotherapy with radiation before or after surgery for cancer that had not spread, you must have been off treatment for at least 12 months.
  • Cancer that has spread to the brain or spinal cord is allowed if it causes no symptoms.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official 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. * List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K E709\_T710delinsD, E709\_T710delinsA, E709\_T710delinsG, L718M, L718P, L718Q, L718V, G719X, G719A, G719C, G719D, G719S, G724S, E736K, I740\_K745dup, I740\_K745dupIPVAIK, I744\_K745insKIPVAI, L747P, L747S, K757M, K757R, V765L, S768I, S768\_V769delinsIL, S768\_V769delinsIM, S768\_V769delinsPL, V769L, V769M, N771G, H773\_V774delinsLM, V774M, R776C, R776H, G779F, L792H, G796S, T854A, T854S, T854I, A647T, R675W, S768C, A755D, A750\_I759delinsPN, T751\_I759delinsN

    Study sites (21)

    CA

    CO

    IL

    MI

    NY

    OH

    PA

    TX

    VA

    WA