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

Primary Purpose

Non-Small-Cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Furmonertinib (160mg)

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Furmonertinib

Arm Description

Furmonertinib (160mg)

Outcomes

Primary Outcome Measures

One-year Progression Free Survival Rate

Percentage of subjects still alive and progression free one year after inclusion in the study.

Secondary Outcome Measures

One-year Overall Survival Rate

Percentage of subjects still alive one year after inclusion in the study.

Progression Free Survival

The time from the first does of the study drugs to the progression of the disease or death for any reason.

Objective Response Rate

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

Adverse Events

Number of participants with adverse events as a measure of safety and tolerability.

Full Information

NCT ID

NCT05255406

First Posted

February 16, 2022

Last Updated

August 2, 2022

Sponsor

Fudan University

Collaborators

Allist Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05255406

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 9, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

Collaborators

Allist Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small-Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Furmonertinib

Arm Type

Experimental

Arm Description

Furmonertinib (160mg)

Intervention Type

Drug

Intervention Name(s)

Furmonertinib (160mg)

Other Intervention Name(s)

AST2818

Intervention Description

160mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (80mg).

Primary Outcome Measure Information:

Title

One-year Progression Free Survival Rate

Description

Percentage of subjects still alive and progression free one year after inclusion in the study.

Time Frame

One year after inclusion

Secondary Outcome Measure Information:

Title

One-year Overall Survival Rate

Description

Percentage of subjects still alive one year after inclusion in the study.

Time Frame

one year after inclusion

Title

Progression Free Survival

Description

The time from the first does of the study drugs to the progression of the disease or death for any reason.

Time Frame

Approximately 2 years following the first dose of study drugs

Title

Objective Response Rate

Description

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

Time Frame

Approximately 2 years following the first dose of study drugs

Title

Adverse Events

Description

Number of participants with adverse events as a measure of safety and tolerability.

Time Frame

Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hui Yu, MD

Phone

+86 13801725650

yhui30@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Yu, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Yu, MD

Phone

+86 13801725650

yhui30@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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