Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years old, Male or Female

Histologically or cytologically confirmed locally advanced or metastatic lung adenocarcinoma not amenable to curative surgery or radiotherapy;

Patients have been confirmed by local laboratory to have one of the following EGFR mutations: 19Del or L858R (single or compound)

Patients had locally advanced NSCLC or metastatic NSCLC without any systemic antitumor therapy

Disqualifiers

NSCLC with predominant squamous cell histology, small cell lung cancer or neuroendocrine carcinoma indicated by histology or cytology test

Patients with other driver oncogenes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation, but not TP53, RB1, BRAC mutation, etc.);

Expected to receive other anti-tumor therapy other than the investigational product during the study

Having received the following therapies: (1) Having been irradiated for > 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;

Trial design

Design model

Single group

Treatments tested in this trial

  • Furmonertinib

    Drug

    Furmonertinib 160mg, once daily, orally. Other Names: AST2818

Treatment groups

144 Participants
are divided into 1 treatment group
Group A: FurmonertinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression Freae Survival (PFS)

The time from the first dose of the study drugs to the progression of the disease or death for any reason according to RECIST 1.1 by investigator

Time frame
Approximately 24 months after the first patient begin study treatment

Secondary outcomes

1

Objective Response Rate (ORR)

Rate of subjects whose tumors are assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.

Time frame
Approximately 12 weeks after the last patient begin study treatment
2

Disease Control Rate (DCR)

Rate of subjects whose tumors are assessed as CR, PR or stable disease (SD) according to RECIST 1.1

Time frame
Approximately 12 weeks after the last patient begin study treatment
3

Overall survival (OS)

The time from the first dose of the study drugs to the death for any reason according to RECIST 1.1

Time frame
Approximately 24 months after the last patient begin study treatment
4

Central Nervous System Objective Response Rate (CNS ORR)

Rate of subjects whose CNS tumors are assessed as complete response(CR) or partial response(PR) according to RECIST 1.1

Time frame
Approximately 12 weeks after the last patient begin study treatment

Other outcomes

Sponsors and contacts

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