Clinical trial NCT05255406: Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Allist Pharmaceuticals, Inc.
First posted: 2022-02-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: One-year Progression Free Survival Rate
timeFrame: One year after inclusion
Secondary outcomes:
measure: One-year Overall Survival Rate
timeFrame: one year after inclusion
measure: Progression Free Survival
timeFrame: Approximately 2 years following the first dose of study drugs
measure: Objective Response Rate
timeFrame: Approximately 2 years following the first dose of study drugs
measure: Adverse Events
timeFrame: Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Hui Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: