Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Cancer Hospital
About this trial
This is a prospective, single-arm, Phase II clinical study aimed at evaluating the efficacy and safety of 160mg fimonertinib in combination with definitive radiotherapy for patients with EGFR uncommon driver mutation-positive, Stage III unresectable lung adenocarcinoma. The primary endpoint is Progression-Free Survival (PFS), assessed by the investigator according to RECIST 1.1 criteria, defined as the time from the first dose to objective disease progression or death (from any cause). Secondary endpoints include PFS by different mutation types, OS, ORR, DCR, as well as adverse events and their severity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of informed consent prior to any study-specific procedures;
Age ≥18years;
ECOG performance status of 0 or 1 with no deterioration within the 2 weeks prior to enrollment, and a life expectancy of ≥12 weeks;
Histologically or cytologically confirmed non-squamous non-small cell lung cancer;
Disqualifiers
Pathological type is pulmonary squamous cell carcinoma or small cell lung cancer;
Known history of hypersensitivity to the active or inactive excipients of firmonertinib, or to drugs with a similar chemical structure or class to the investigational drug;
Confirmed presence of EGFR exon 19 deletion or exon 21 L858R mutation;
Presence of metastatic disease, or assessed as unsuitable for definitive radiotherapy; or unable to undergo definitive radiotherapy due to extensive tumor volume resulting in normal tissue radiation doses exceeding dose constraints;
Trial design
Design model
Single group
Treatments tested in this trial
Firmonertinib
DrugOral administration
Definitive Thoracic Radiotherapy
RadiationConformal radiotherapy delivered to the primary tumor and involved regional lymph nodes.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Firmonertinib combined with definitive radiotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival
the time from the first dose of study treatment (or treatment initiation in single-arm trials) to disease progression or death from any cause, whichever occurs first.
Time frame
From enrollment until 30 months after the completion of treatmentSecondary outcomes
1
Objective response rate
Investigator-assessed objective response rate (complete response + partial response) per RECIST v1.1
Time frame
From enrollment until 30 months after the completion of treatment2
Disease control rate
Investigator-assessed objective response rate (complete response + partial response) per RECIST v1.1
Time frame
From enrollment until 30 months after the completion of treatment3
Progression-Free Survival by Mutation Type
Investigator-assessed (per RECIST v1.1) time from first study treatment to objective disease progression or death from any cause, by mutation type
Time frame
From enrollment until 30 months after the completion of treatment4
Overall Survival
Investigator-assessed time from the first dose of study treatment to death from any cause
Time frame
From enrollment until 60 months after the completion of treatmentSponsors and contacts
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Source ClinicalTrials.gov