NCT04706949

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lung Cancer, Non-small Cell

Interventions

Type	Name	Description
DRUG	Pyrotinib combined with pemetrexed plus carboplatin	1. 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. 2. 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.

Timeline

• Start date: 2020-12-07
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2021-01-13
• Last updated: 2021-01-13

Locations

1 site across 1 country: China