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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborator: Allist Pharmaceuticals, Inc.
• Treatments: Aflutinib

Criteria

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.