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
Verified date | August 2022 |
Source | Fudan University |
Contact | Hui Yu, MD |
Phone | +86 13801725650 |
yhui30[@]hotmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University | Allist Pharmaceuticals, Inc. |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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