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A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer

ConditionNon Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Cancer Hospital

About this trial

Exploring the efficacy and safety of adaptively adjusting treatment regimens based on ctDNA (MRD) status for EGFR mutation-positive NSCLC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign a written informed consent before implementing any trial-related procedures;

At least 18 years of age;

Have histologically or cytologically confirmed non-squamous non-small cell lung cancer.

Confirmed presence of EGFR-sensitive mutation-positive by tumor histology, cytology, hematology, or pleural effusion supernatant;

Disqualifiers

The pathology is small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and non-small cell lung cancer (NSCLC);

received systemic anti-tumor therapy within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine therapy with anti-tumor indications), etc.;

received any investigational drug therapy within 4 weeks before treatment;

received high-dose immunosuppressive drugs (systemic glucocorticoids exceeding 10mg/day of prednisone or its equivalent dose) within 4 weeks before treatment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Firmonertinib

    Drug

    80mg QD

  • Firmonertinib/pemetrexed/Carboplatin

    Drug

    Drug: Firmonertinib daily and pemetrexed plus carboplatin on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by firmonertinib daily with pemetrexed maintenance every 3 weeks.

  • Firmonertinib/pemetrexed/Carboplatin/Bevacizumab

    Drug

    Drug: Firmonertinib daily and pemetrexed plus carboplatin on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by firmonertinib daily with pemetrexed and bevacizumab maintenance every 3 weeks.

Treatment groups

154 Participants
are divided into 4 treatment groups
Group A: Arm A1Experimental treatment 1 intervention
Group B: Arm A2Experimental treatment 1 intervention
Group C: Arm B1Experimental treatment 1 intervention
Group D: Arm B2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Time frame
through study completion, an average of 2 years

Secondary outcomes

1

Overall Survival (OS)

Time frame
through study completion, an average of 4 years
2

Objective Response Rate (ORR)

Time frame
through study completion, an average of 2 years
3

Disease Control Rate (DCR)

Time frame
through study completion, up to 2 years
4

Duration of Response (DoR)

Time frame
through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

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

Anhui Provincial Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

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