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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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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 EGFR PACC EGFR Uncommon Mutations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Firmonertinib 240 mg

Group Type EXPERIMENTAL

Firmonertinib

Intervention Type DRUG

240 mg oral, daily firmonertinib tablet

EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice

Group Type ACTIVE_COMPARATOR

EGFR-TKI inhibitor based on investigator's choice

Intervention Type DRUG

osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Interventions

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Firmonertinib

240 mg oral, daily firmonertinib tablet

Intervention Type DRUG

EGFR-TKI inhibitor based on investigator's choice

osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Intervention Type DRUG

Other Intervention Names

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AST2818

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No