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

Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: Furmonertinib (160mg)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05255406

FMTN-IIT-2021-001

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;
11. Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Furmonertinib

Experimental group

Description:

Furmonertinib (160mg)

Treatment:

Drug: Furmonertinib (160mg)