Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)

A Prospective, Single-arm, Phase 2 Clinical Trial of Furmonertinib as the First-line Treatment in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC

The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC.

Study Overview

• Status: Recruiting
• Conditions: Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: Furmonertinib (160mg)

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hui Yu, MD; Phone Number: +86 13801725650; Email: yhui30@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Hui Yu, MD; Phone Number: +86 13801725650; Email: yhui30@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects aged ≥18 years old;
2. Locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology (stage ⅢB-Ⅳ, according to the 8th Edition of the AJCC Staging system);
3. The tumour harbours one of the most common EGFR mutations (19del or L858R);
4. The programmed death-ligand 1 (PD-L1) tumoral expression is positive;
5. No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
6. According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline;
7. ECOG performance status score 0-2；
8. Subjects have voluntarily participated, signed and dated informed consent.

Exclusion Criteria:

1. Lung squamous carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma) and small cell lung cancer;
2. Subjects have no measurable tumor lesion at baseline;
3. Subjects with spinal cord compression or symptomatic brain metastases;
4. Subjects are suitable for surgery;
5. Previous therapy with platinum-based chemotherapy, EGFR-TKIs, or anti-PD1/PD-L1 agents;
6. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 × ULN, or serum total bilirubin (TBIL)>1.5 × ULN, or Cr>1.0×ULN;
7. Absolute value of neutrophil (ANC)<1.5 × 109/L, or platelet (PLT) count<75 × 109/L, or hemoglobin (HGB)<90 g/L;
8. Any of the following disease within 12 months: myocardial infarction, severe/unstable stenocardia, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident;
9. Women who are pregnancy or lactation, or fertile but not using contraception;
10. Suffering from other serious acute or chronic physical or mental problems;
11. Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Furmonertinib; Furmonertinib (160mg)	Drug: Furmonertinib (160mg); 160mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (80mg).; Other Names: AST2818

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One-year Progression Free Survival Rate	Percentage of subjects still alive and progression free one year after inclusion in the study.	One year after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One-year Overall Survival Rate	Percentage of subjects still alive one year after inclusion in the study.	one year after inclusion
Progression Free Survival	The time from the first does of the study drugs to the progression of the disease or death for any reason.	Approximately 2 years following the first dose of study drugs
Objective Response Rate	Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.	Approximately 2 years following the first dose of study drugs
Adverse Events	Number of participants with adverse events as a measure of safety and tolerability.	Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Allist Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Hui Yu, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Aflutinib
• Other Study ID Numbers: FMTN-IIT-2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No