Firmonertinib Plus Chemotherapy for Unresectable EGFR PACC-Mutant Stage III Lung Cancer: A Phase II Study
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital
About this trial
This is a prospective, single-arm, multicenter Phase II clinical study. It aims to evaluate the efficacy and safety of Firmonertinib combined with chemotherapy in patients with unresectable Stage III lung adenocarcinoma harboring EGFR PACC mutations. Participants will receive Firmonertinib combined with standard chemotherapy. The primary objective is to assess the objective response rate (ORR). This study will provide important evidence for a potential new treatment option for this specific patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed locally advanced (Stage IIIA-IIIC according to the AJCC 9th edition) lung adenocarcinoma that is assessed by the investigator as unresectable or unsuitable for surgical resection.
Confirmed presence of EGFR PACC mutations by genetic testing at a tertiary Grade A hospital.
No prior local or systemic anti-tumor therapy for Stage III non-small cell lung cancer, including standard chemotherapy, biological therapy, targeted therapy, immunotherapy, or investigational therapy.
According to RECIST 1.1 criteria, at least one measurable lesion that has not been previously irradiated and has not undergone tissue biopsy during the screening period.
Disqualifiers
Pathological type of squamous cell carcinoma or small cell lung cancer.
Known history of severe hypersensitivity reactions to the active or inactive excipients of Firmonertinib, or to drugs with a similar structure or class to Firmonertinib.
Prior systemic anti-tumor therapy for NSCLC, including investigational drug therapy.
History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids, or current pneumonitis/interstitial lung disease requiring steroid therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Firmonertinib
DrugFirmonertinib mesylate tablets, 160 mg, oral administration, once daily. Administered during induction and consolidation phases.
Platinum-based chemotherapy
DrugPemetrexed (500 mg/m²) combined with Carboplatin or Cisplatin. Administered during the 3-4 cycles of induction therapy
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Firmonertinib Combined with ChemotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST v1.1 criteria
Time frame
From baseline to the end of study treatment (up to approximately 36 months)Secondary outcomes
1
1-year and 3-year Event-Free Survival (EFS) Rate
Proportion of participants who are event-free at 1 year and 3 years from enrollment. Events are defined as disease progression, relapse, or death from any cause
Time frame
At 1 year and 3 years post-enrollment2
Surgical Conversion Rate
Proportion of participants with unresectable disease at baseline who achieve resectability and undergo surgery after induction therapy
Time frame
After 3-4 cycles of induction therapy (up to approximately 6 months)3
R0 Resection Rate
Proportion of participants who undergo surgical resection with microscopically negative margins (R0 resection)
Time frame
At the time of surgery (up to approximately 6 months)4
Major Pathological Response (MPR) and Pathological Complete Response (pCR) Rate
Proportion of participants achieving MPR (≤10% viable tumor cells) or pCR (no viable tumor cells) in resected specimens
Time frame
At the time of surgery (up to approximately 6 months)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: