High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib

NCT06394674 | Recruiting Phase 2

• 1 other identifier: CHEC2023-155
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.

Conditions

Non-Small Cell Lung Cancer

Keywords

furmonertinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response

  Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment

Secondary Outcomes (3)

• Progression-free survival (PFS)

  The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 12 months after the first patient begin study treatment

• Disease Control Rate (DCR)

  Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment

• Duration of Response (DoR)

  Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 12 months from the first patient begin study treatment

Other Outcomes (1)

• Adverse Events

  From the start of study drug to 30 days after the last dose of study drug

Study Arms (2)

Group A: Furmonertinib 160mg QD

EXPERIMENTAL

Furmonertinib (AST2818) 160mg QD. All patients enrolled into this group will receive furmonertinib 160mg daily.

Drug: Furmonertinib

Group B: Furmonertinib 240mg QD

EXPERIMENTAL

Furmonertinib (AST2818) 240mg QD. All patients enrolled into this group will receive furmonertinib 240mg daily.

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

Drug: Furmonertinib

Also known as: AST2818

Group A: Furmonertinib 160mg QD; Group B: Furmonertinib 240mg QD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic lung adenocarcinoma
• Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
• Previous genetic testing for a definite EGFR-sensitive mutation and imaging-confirmed extracranial lesion progression after first-line treatment with Osimertinib; or previous genetic testing for a definite T790M mutation and imaging-confirmed extracranial lesion progression after second-line treatment with Osimertinib.
• Pre-existing clinical benefit after treatment with Osimertinib, including CR, PR, SD (duration \>6 months);
• Patients with at least 1 measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
• Normal functioning of major organs
• Pre-menopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose of the drug
• Subjects volunteered and signed a written informed consent form.

You may not qualify if:

• Previous chemotherapy or immunotherapy
• Patients with non-lung adenocarcinoma, including squamous lung cancer or mixed histological types
• Progression of imaging-confirmed extracranial lesions after prior Osimertinib treatment with accessible treatment options after genetic testing
• Patients with symptomatic brain metastases, meningeal metastases or spinal cord compression
• Any unrecovered CTCAE \> grade 1 toxicity reaction following prior Osimertinib treatment at the start of study drug therapy
• Other malignant tumors within 5 years or history of other malignant tumours; except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid, superficial bladder tumors, etc.
• History of interstitial pneumonia with previous diagnosis

Sponsors & Collaborators

• Changhai Hospital: lead
• The General Hospital of Eastern Theater Command: collaborator
• Shanghai Chest Hospital: collaborator
• Fujian Provincial Hospital: collaborator
• Shanghai Changzheng Hospital: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• The First People's Hospital of Changzhou: collaborator
• Second Affiliated Hospital of Wannan Medical College: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-05

Locations

CN (1)