Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment (NCT04706949) | Clinical Trial Compass
UnknownPhase 2
Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment
China26 participantsStarted 2020-12-07
Plain-language summary
A prospective, single center, single arm, phase II clinical trial of Pyrotinib combined with pemetrexed plus carboplatin in the first-line treatment of patients with HER2 mutant or amplified recurrent / metastatic non-small cell lung cancer
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged≥18 and \<75 years.
* Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to UICC 2017.
* ECOG performance status of 0 to 1.
* Life expectancy of more than 3 months.
* Confirmed HER2 mutation and amplification by Central Laboratory. Direct sequencing (RT-PCR or ARMS-PCR) or second generation sequencing (NGS) was used for HER2 mutation, and fluorescence in situ hybridization (FISH) or ngs was used for HER2 amplification;
* At least one RECIST 1.1 defined measurable lesions.
* Patients who had not received systemic treatment for advanced / metastatic NSCLC in the past but had disease progression more than 12 months after receiving neoadjuvant therapy or the last use of adjuvant therapy could be enrolled.
* Required laboratory values including following parameters:ANC≥1.5×109/L,Platelet count≥90×109/L,Hemoglobin≥90 g/L;Total bilirubin:≤ 1.5×upper limit of normal, ULN, ALT and AST≤ 2.0×ULN; BUN and Cr: ≤1.5 x ULN;creatine clearance rate: ≥ 50 mL/min, LVEF: ≥ 50%; QTcF:\< 470 ms for female and \< 450 ms for male.
* Signed informed consent.
Exclusion Criteria:
* Previous therapy with other HER2 inhibitors.
* Inability to swallow、chronic diarrhea and intestinal obstruction that affect the drug taking and absorption.
* There is unstable third space effusion (such as large amount of pleural effusion and ascites).
* Received radiotherapy, chemotherapy, surgery or other targeted therapy for non-small cell lung adenoca…
What they're measuring
1
PFS
Timeframe: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)]