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

Non-Small-Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255406
• Other study ID #: FMTN-IIT-2021-001
• Status: Recruiting
• Phase: Phase 2
• Start date: December 9, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: Fudan University
• Contact: Hui Yu, MD
• Phone: +86 13801725650
• Email: yhui30[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?B-?, 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small-Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Allist Pharmaceuticals, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One-year Overall Survival Rate	Percentage of subjects still alive one year after inclusion in the study.	one year after inclusion
Secondary	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
Secondary	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
Secondary	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