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

NCT05255406 | Unknown Phase 2

• 1 other identifier: FMTN-IIT-2021-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• One-year Overall Survival Rate

  one year after inclusion

• Progression Free Survival

  Approximately 2 years following the first dose of study drugs

• Objective Response Rate

  Approximately 2 years following the first dose of study drugs

• Adverse Events

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

Study Arms (1)

Furmonertinib

EXPERIMENTAL

Furmonertinib (160mg)

Drug: Furmonertinib (160mg)

Interventions

Furmonertinib (160mg) DRUG

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

Also known as: AST2818

Furmonertinib

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Allist Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hui Yu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Yu, MD

CONTACT

+86 13801725650; yhui30@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate senior doctor

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 24, 2022
• Study Start: December 9, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)