Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)

NCT04965831 | Not Yet Recruiting Phase 2

• 1 other identifier: AST-PMR2003
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.

Conditions

Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1

  Approximately 8 weeks following the first dose of study drug

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  Approximately 8 weeks following the first dose of study drug

• Progression free survival (PFS)

  Approximately 3 years following the first dose of study drug

• Disease free survival (DFS)

  Approximately 3 years following the first dose of study drug

• Adverse Events (AEs)

  From the start of study drug to 28 days after the last dose of study drug

Other Outcomes (2)

• Circulating tumor DNA clearance rate

  Approximately 8 weeks following the first dose of study drug

• Minimal residual disease rate

  Approximately 12 weeks following the first dose of study drug

Study Arms (1)

Furmonertinib

EXPERIMENTAL

Furmonertinib as perioperation therapy

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery.

Also known as: AST2818

Furmonertinib

Eligibility Criteria

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

You may qualify if:

• The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study.
• Primary lung adenocarcinoma diagnosed histologically/cytologically.
• Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators.
• EGFR mutation positive (19Del or L858R, with or without T790M)
• The presence of at least one measurable lesion and suitable for accurate repeated measurements.
• ECOG performance status 0-1.
• For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.

You may not qualify if:

• Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma.
• Patients with EGFR exon 20 insertion mutation.
• Exposure to other antitumor therapies prior to enrolment.
• Major surgery was performed in the four weeks prior to the first dosing of the study drug.
• Pregnant or lactating female patients.
• Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration.
• Have a history of or present complications with other malignancies.
• Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study.
• ECG QT interval prolongation or associated risk.
• A history of interstitial pneumonia or related risk.
• Inadequate bone marrow or organ reserve.
• Other circumstances that are not suitable for participation in this study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Allist Pharmaceuticals, Inc.: collaborator

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Changli Wang, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changli Wang, MD

CONTACT

+86 022-23340123; aswindcc@126.com

Study Design

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

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 16, 2021
• Study Start: August 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2026
• Last Updated: July 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share