Non-Small-Cell Lung Cancer
Conditions
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.
Interventions
DRUGFurmonertinib (160mg)
160mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (80mg).
Sponsors
Allist Pharmaceuticals, Inc.
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year Progression Free Survival Rate | One year after inclusion | Percentage of subjects still alive and progression free one year after inclusion in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| One-year Overall Survival Rate | one year after inclusion | Percentage of subjects still alive one year after inclusion in the study. |
| Progression Free Survival | Approximately 2 years following the first dose of study drugs | The time from the first does of the study drugs to the progression of the disease or death for any reason. |
| Objective Response Rate | Approximately 2 years following the first dose of study drugs | Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1. |
| Adverse Events | Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment | Number of participants with adverse events as a measure of safety and tolerability. |
Countries
China
Contacts
Primary ContactHui Yu, MD
Outcome results
None listed