2023-07-11T00:00:00.000+10:00
Ongoing

Furmo-004

Furmo-004
Lung cancer

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Trial overview

Topic

Lung cancer

Eligibility criteria

Key Inclusion Criteria:

  • Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
  • Documented validated results confirming the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
  • No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
  • Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.

Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.

Study details

Primary Outcome Measures:

  • Progression Free Survival (PFS) determined by blinded independent central review (BICR) [ Time Frame: Up to 32 months after first dose ]

Secondary Outcome Measures:

  • Overall Survival (OS) [ Time Frame: Up to 62 months after first dose ]
  • PFS determined by investigator assessment [ Time Frame: Up to 36 months after first dose ]
  • Overall response rate (ORR) [ Time Frame: Up to 36 months after first dose ]
  • Duration of response (DOR) [ Time Frame: Up to 36 months after first dose ]
  • Time to second Progression Free Survival (PFS2) [ Time Frame: Up to 36 months after first dose ]
  • PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline [ Time Frame: Up to 36 months after first dose ]
  • Time to central nervous system (CNS) metastases by BICR [ Time Frame: Randomization up to ≤30 days after last dose ]
  • CNS ORR evaluated by BICR [ Time Frame: Randomization up to ≤30 days after last dose ]
  • CNS DOR evaluated by BICR [ Time Frame: Randomization up to ≤30 days after last dose ]
  • CNS PFS evaluated by BICR [ Time Frame: Randomization up to ≤30 days after last dose ]
  • Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) [ Time Frame: Randomization up to ≤30 days after last dose ]

QLQ-C30 is a cancer-specific questionnaire comprised of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).

  • Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13) [ Time Frame: Randomization up to ≤30 days after last dose ]

QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication.

  • Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ) [ Time Frame: Randomization up to ≤30 days after last dose ]

NSCLC-SAQ consists of 7 items assessing 5 NSCLC symptom concepts: cough, pain, dyspnea, fatigue, and poor appetite.

  • Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib [ Time Frame: Up to 36 months after first dose ]
  • Plasma concentrations of furmonertinib and its major metabolite (AST5902) [ Time Frame: Up to 36 months after first dose ]
Further information

For more information regarding this clinical trial click here.

Location
North Shore :::

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