Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment

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

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

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer, Non-small Cell
• Intervention / Treatment: Drug: Pyrotinib combined with pemetrexed plus carboplatin

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Cancer hospital Fudan University
      • Contact: wang jia lei, DOCTOR; Phone Number: 18017312689; Email: haitunqiao@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 adenocarcinoma within 4 weeks before taking the study drug for the first time.
• Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1).
• Patients with active brain metastasis (without medical control), cancerous meningitis, spinal cord compression, or diseases of brain or pia mater found by CT or MRI examination during screening (patients with brain metastasis who had completed treatment or stable symptoms within 28 days before taking the study drug for the first time can be enrolled, but they need to be confirmed as having no symptoms of cerebral hemorrhage by MRI, CT or venography evaluation).
• Participated in other drug clinical trials within the past 4 weeks before start of therapy.
• Other malignant tumors in the past 5 years, excluding cervical carcinoma in situ, basal cell carcinoma of skin or squamous cell carcinoma of skin.
• At the same time receive any other anti-tumor treatment, such as immune agents and anti angiogenesis inhibitors.
• Those with allergic constitution or known allergic history to the drug components of the scheme.
• Active infection(judged by the researcher).
• Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
• According to the judgment of the researchers, there are concomitant diseases (such as uncontrolled hypertension, diabetes, thyroid disease, etc.) that seriously endanger the safety of patients or affect the completion of the study.
• Known history of neurological or psychiatric disease, including epilepsy or dementia.

Any of the other conditions of which researchers believe that the patient is not fit to take part in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pyrotinib combined with pemetrexed plus carboplatin

Drug: Pyrotinib combined with pemetrexed plus carboplatin; Pyrotinib: oral administration within 30 minutes after breakfast, 400mg / day, continuous administration for 21 days as a cycle; each continuous pause time and the cumulative pause time of each cycle should not exceed 14 days. It is allowed to suspend the drug for many times due to adverse events.; Pemetrexed: the recommended dosage is 500mg / m2, once every three weeks. 3) Carboplatin: the dosage was determined according to Calvert formula, in which AUC was 5mg / ml / min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression free survival	from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)]

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Lung Cancer, Non-small Cell
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Carboplatin; Pemetrexed
• Other Study ID Numbers: BLTN-HER2-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No