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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

ConditionsNon-Small-Cell Lung CancerMetastatic Non-Small-Cell Lung CancerAdvanced Non-Small-Cell Lung CancerEGFR P-Loop and Alpha C-Helix CompressingEGFR PACCEGFR Uncommon Mutations
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorArriVent BioPharma, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Firmonertinib

    Drug

    240 mg oral, daily firmonertinib tablet

  • EGFR-TKI inhibitor based on investigator's choice

    Drug

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

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: Firmonertinib 240 mgExperimental treatment 1 intervention
Group B: EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choiceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS) determined by blinded independent central review (BICR)

PFS is defined as the time from randomization to the first occurrence of disease progression as determined by BICR using RECIST v1.1, or death from any cause, whichever occurs first.

Time frame
Until progression or death, assessed up to approximately 4 years
2

Confirmed overall response rate (ORR) as determined by BICR

Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on BICR assessment relative to the total number of participants.

Time frame
Until progression or death, assessed up to approximately 3 years

Secondary outcomes

1

Overall survival (OS)

OS is defined as the time from randomization to death from any cause.

Time frame
Until death, assessed up to approximately 5 years
2

Investigator-assessed PFS

Investigator-assessed PFS is defined as the time from randomization to the first documented disease progression or death, whichever occurs first, based on investigator assessment per RECIST v1.1.

Time frame
Until progression or death, assessed up to approximately 4 years
3

Investigator-assessed confirmed ORR

Investigator-assessed confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on investigator assessment relative to the total number of participants.

Time frame
Until progression or death, assessed up to approximately 3 years
4

Duration of response (DOR)

DOR is defined as the time from first documented evidence of CR or PR until the first documented evidence of disease progression or death, whichever occurs first.

Time frame
Until progression or death, assessed up to approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ArriVent BioPharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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