ctDNA-MRD Based Adjuvant Targeted Therapy for EGFR Positive Stage I Lung Adenocarcinomas

NCT05079022 | Unknown Phase 1

• 1 other identifier: Y-2021 AST/zd-0105
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility and effectiveness of ctDNA-MRD based adjuvant furmonertinib therapy in EGFR mutation-positive stage I lung adenocarcinoma patients after complete surgical resection.

Conditions

Adenocarcinoma of Lung

Keywords

lung adenocarcinoma; circulating tumor DNA; minimal residual disease; EGFR; furmonertinib

Outcome Measures

Primary Outcomes (1)

• Clearance of ctDNA at 6 months

  To estimate the percentage of patients with undetectable ctDNA at 6 months after adjuvant furmonertinib therapy in stage I lung adenocarcinoma patients who underwent R0 resection and have postoperatively detectable ctDNA prior to adjuvant therapy.

  6 months

Secondary Outcomes (2)

• Relapse-free survival (RFS)

  Through study completion, an average of 3 years

• Clearance of ctDNA at 12 months

  12 months

Other Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  Through study completion, an average of 3 years

• Genomic changes of ctDNA

  0, 3, 6, 12, 18, 24, 30, 36 months

• Relationship between radiomics features and ctDNA status

  pre-surgery and 3 days after the surgery

Study Arms (1)

Furmonertinib

EXPERIMENTAL

ctDNA-MRD positive participants received 3 years of furmonertinib once daily as adjuvant therapy after radical surgery until disease progression or unacceptable toxicity occurs.

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

Furmonertinib at 80mg dose will be administered orally once daily.

Also known as: AST2818, AST5902

Furmonertinib

Eligibility Criteria

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

You may qualify if:

• Stage I lung adenocarcinoma patients underwent complete surgical resection with negative margins (R0) and harbor sensitizing EGFR mutations (exon 19 and/or exon 21).
• Positive ctDNA after surgery and prior to adjuvant therapy (4 weeks after surgery).
• Completely recovered from surgery before adjuvant treatment and showed no signs of tumor recurrence in imaging.
• Adequate organ function: 1) Hemoglobin ≥ 9.0 g/dL; 2)Absolute neutrophil count (ANC) ≥ 1500 cells/mm3; 3) Platelets ≥ 90,000/mm3; 4) AST, ALT ≤ 2.5 x ULN; 5) Total bilirubin ≤ 1.5 x ULN; 6) Serum creatinine ≤ 1.5x ULN and calculated creatinine clearance ≥ 60ml/min.
• Age \>18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Females must have a negative pregnancy test within 7 days prior to the start of dosing if of child-bearing potential.
• Males and females of reproductive potential who are sexually active must agree to use adequate contraception prior to entry, during the process and 8 weeks after drug withdrawal.
• Written informed consent.
• Compliance with the protocol.
• Ability to swallow the formulated product.

You may not qualify if:

• Any type of systemic anticancer therapy for lung adenocarcinomas, including chemotherapy, targeted therapy or immunotherapy.
• Any prior local radiotherapy for lung adenocarcinomas.
• Clinical objective evidence (pathology or imaging) to confirm disease recurrence before the start of adjuvant therapy.
• Allergy to furmonertinib or any ingredients.
• Past medical history of ILD, drug-induced ILD or any evidence of clinically active ILD; CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis.
• Any evidence of uncontrolled systemic diseases, including active infection, uncontrolled hypertension, unstable angina, angina within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] Grade II), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medical treatment, liver diseases, kidney diseases or metabolic diseases.
• Known history of human immunodeficiency virus (HIV) infection.
• Pregnant or lactating women.
• History of neurological or psychiatric disorders, including epilepsy or dementia.
• Other judgments by the Investigator that the patient should not participate in the study.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beijing CSCO-Allist Cancer Research Foundation: collaborator
• Shanghai Allist Pharmaceutical Technology Co., Ltd.: collaborator
• Guangzhou Burning Rock Medical Examination Institute Co., Ltd.: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Neoplasm, Residual

Interventions

aflutinib; AST5902

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fan Yang, MD

  Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Fan Yang, MD

CONTACT

+86-010-88326657; yangfan@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Thoracic Surgery

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 15, 2021
• Study Start: October 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2024
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

CN (1)