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

UNKNOWNPHASE2

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

NCT05255406•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 9, 2021

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2024

Last Updated

August 4, 2022

Enrollment

ESTIMATED participants

Conditions

Non-Small-Cell Lung Cancer

Interventions

Furmonertinib (160mg)

DRUG

Contacts

Hui Yu, MD

CONTACT

+86 13801725650 yhui30@hotmail.com

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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