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Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma

ConditionsNSCLCEGFR Positive Non-small Cell Lung CancerNeoadjuvant Therapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute

About this trial

An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Prior to the initiation of any study-related procedures, including examinations, sample collection, or analyses, written informed consent was obtained from all participating patients.

Postmenopausal, defined as older than 50 years of age and having no menstruation for at least 12 months after stopping all exogenous hormone therapy.

For women under 50 years old, if there is no menstruation for 12 months or longer after stopping exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are in the postmenopausal range, they are considered postmenopausal.

Documented irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation.

Disqualifiers

1.Tumors with squamous cell carcinoma, large cell carcinoma, or neuroendocrine components such as small cell carcinoma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Firmonertinib 80mg qd oral for 8 weeks.

    Drug

    Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.

  • Firmonertinib 160mg qd oral for 8 weeks.

    Drug

    Participations will receive the drug treatments preoperatively: Firmonertinib 160mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.

  • Firmonertinib 80mg qd oral for 16 weeks.

    Drug

    Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 16 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major Pathological Response (MPR) Rate

Defined as the time from the date of surgery to the first occurrence of local or distant disease recurrence, or death from any cause.

Time frame
At the time of surgery (approximately Week 12 from treatment initiation for Cohort 1 and Cohort 2, and Week 20 for Cohort 3), Assessed up to 3 years

Secondary outcomes

1

Objective Response Rate (ORR)

The percentage of patients who achieve a Complete Response (CR) or Partial Response (PR) based on radiological evaluation (e.g., RECIST v1.1).

Time frame
From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
2

Disease Control Rate (DCR)

The percentage of patients who achieve CR, PR, or Stable Disease (SD) based on radiological evaluation (e.g., RECIST v1.1).

Time frame
From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
3

Pathological Complete Response (pCR) Rate

The proportion of patients with no remaining viable tumor cells (ypT0N0) in the resected primary tumor and sampled lymph nodes

Time frame
From baseline up to the pre-operative tumor assessment (at Week 8 for Cohort 1 and Cohort 2, and at Week 16 for Cohort 3). Assessed up to 3 years
4

R0 Resection Rate

The percentage of patients who achieve radical tumor resection with microscopically negative margins (R0 resection) as confirmed by histopathological analysis.

Time frame
At the time of surgery (approximately Week 12 from treatment initiation for Cohort 1 and Cohort 2, and Week 20 for Cohort 3) compared to baseline clinical staging. Assessed up to 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Peking University Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: