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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: Furmonertinib (160mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged ≥18 years old; 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); The tumour harbours one of the most common EGFR mutations (19del or L858R); The programmed death-ligand 1 (PD-L1) tumoral expression is positive; No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC; According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline; ECOG performance status score 0-2； Subjects have voluntarily participated, signed and dated informed consent. Exclusion Criteria: Lung squamous carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma) and small cell lung cancer; Subjects have no measurable tumor lesion at baseline; Subjects with spinal cord compression or symptomatic brain metastases; Subjects are suitable for surgery; Previous therapy with platinum-based chemotherapy, EGFR-TKIs, or anti-PD1/PD-L1 agents; Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 × ULN, or serum total bilirubin (TBIL)>1.5 × ULN, or Cr>1.0×ULN; Absolute value of neutrophil (ANC)<1.5 × 109/L, or platelet (PLT) count<75 × 109/L, or hemoglobin (HGB)<90 g/L; 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; Women who are pregnancy or lactation, or fertile but not using contraception; Suffering from other serious acute or chronic physical or mental problems; Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |