OncoMatch/Clinical Trials/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
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)
Is NCT07185997 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments including Firmonertinib and EGFR-TKI inhibitor based on investigator's choice for non-small-cell lung cancer.
Treatment: Firmonertinib · EGFR-TKI inhibitor based on investigator's choice — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR e709x
List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K ...
Required: EGFR e709a
List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K ...
Required: EGFR e709h
List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K ...
Required: EGFR e709v
List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K ...
Required: EGFR e709k
List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K ...
Required: EGFR e709_t710delinsd
List of eligible PACC mutations: ... E709_T710delinsD ...
Required: EGFR e709_t710delinsa
List of eligible PACC mutations: ... E709_T710delinsA ...
Required: EGFR e709_t710delinsg
List of eligible PACC mutations: ... E709_T710delinsG ...
Required: EGFR l718m
List of eligible PACC mutations: ... L718M ...
Required: EGFR l718p
List of eligible PACC mutations: ... L718P ...
Required: EGFR l718q
List of eligible PACC mutations: ... L718Q ...
Required: EGFR l718v
List of eligible PACC mutations: ... L718V ...
Required: EGFR g719x
List of eligible PACC mutations: ... G719X ...
Required: EGFR g719a
List of eligible PACC mutations: ... G719A ...
Required: EGFR g719c
List of eligible PACC mutations: ... G719C ...
Required: EGFR g719d
List of eligible PACC mutations: ... G719D ...
Required: EGFR g719s
List of eligible PACC mutations: ... G719S ...
Required: EGFR g724s
List of eligible PACC mutations: ... G724S ...
Required: EGFR e736k
List of eligible PACC mutations: ... E736K ...
Required: EGFR i740_k745dup
List of eligible PACC mutations: ... I740_K745dup ...
Required: EGFR i740_k745dupipvaik
List of eligible PACC mutations: ... I740_K745dupIPVAIK ...
Required: EGFR i744_k745inskipvai
List of eligible PACC mutations: ... I744_K745insKIPVAI ...
Required: EGFR l747p
List of eligible PACC mutations: ... L747P ...
Required: EGFR l747s
List of eligible PACC mutations: ... L747S ...
Required: EGFR k757m
List of eligible PACC mutations: ... K757M ...
Required: EGFR k757r
List of eligible PACC mutations: ... K757R ...
Required: EGFR v765l
List of eligible PACC mutations: ... V765L ...
Required: EGFR s768i
List of eligible PACC mutations: ... S768I ...
Required: EGFR s768_v769delinsil
List of eligible PACC mutations: ... S768_V769delinsIL ...
Required: EGFR s768_v769delinsim
List of eligible PACC mutations: ... S768_V769delinsIM ...
Required: EGFR s768_v769delinspl
List of eligible PACC mutations: ... S768_V769delinsPL ...
Required: EGFR v769l
List of eligible PACC mutations: ... V769L ...
Required: EGFR v769m
List of eligible PACC mutations: ... V769M ...
Required: EGFR n771g
List of eligible PACC mutations: ... N771G ...
Required: EGFR h773_v774delinslm
List of eligible PACC mutations: ... H773_V774delinsLM ...
Required: EGFR v774m
List of eligible PACC mutations: ... V774M ...
Required: EGFR r776c
List of eligible PACC mutations: ... R776C ...
Required: EGFR r776h
List of eligible PACC mutations: ... R776H ...
Required: EGFR g779f
List of eligible PACC mutations: ... G779F ...
Required: EGFR l792h
List of eligible PACC mutations: ... L792H ...
Required: EGFR g796s
List of eligible PACC mutations: ... G796S ...
Required: EGFR t854a
List of eligible PACC mutations: ... T854A ...
Required: EGFR t854s
List of eligible PACC mutations: ... T854S ...
Required: EGFR t854i
List of eligible PACC mutations: ... T854I ...
Required: EGFR a647t
List of eligible PACC mutations: ... A647T ...
Required: EGFR r675w
List of eligible PACC mutations: ... R675W ...
Required: EGFR s768c
List of eligible PACC mutations: ... S768C ...
Required: EGFR a755d
List of eligible PACC mutations: ... A755D ...
Required: EGFR a750_i759delinspn
List of eligible PACC mutations: ... A750_I759delinsPN ...
Required: EGFR t751_i759delinsn
List of eligible PACC mutations: ... T751_I759delinsN ...
Prior therapy
Cannot have received: systemic anticancer therapy for locally advanced or metastatic NSCLC
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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Jude Medical Center · Fullerton, California
- USC/Norris Comprehensive Cancer Center · Los Angeles, California
- Providence St. Joseph Hospital · Orange, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- UCSF Medical Center-Mission Bay · San Francisco, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07185997 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy for locally advanced or metastatic NSCLC disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR e709x is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR e709a is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR e709h is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages