PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC

• Sponsor: Yongchang Zhang (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04144569
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 71
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer

Condition or Disease	Intervention/Treatment	Phase
HER2 Insertion Mutation Positive Advanced NSCLC	Drug: PD-1 Combined With Pyrotinib	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group AssignmentSingle Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer
• Actual Study Start Date: Jan 30, 2019
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PD-1 Combined With Pyrotinib PD-1 combined With pyrotinib used fo first-line chemotherapy failedr HER2 Insertion mutation positive advanced NSCLC	Drug: PD-1 Combined With Pyrotinib; PD-1 Combined With Pyrotinib

Outcome Measures

Primary Outcome Measures

1. PFS [Approximately 1 years]

   Progression free survival

Secondary Outcome Measures

1. ORR [Approximately 1 years]

   To measure the patients's overall response rate

2. OS [Approximately 1 years]

   Overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Advanced non-small cell lung cancer confirmed by histology or cytology

• HER2 insertion mutation-positive

• Failure with first-line standard chemotherapy

• with measurable lesions.

Exclusion Criteria:

• no measurable tumor lesions

• Patients received PD-1 or Pyrotinib before

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunan Provincal Tumor Hospital	Changsha	Hunan	China	410013

Sponsors and Collaborators

• Yongchang Zhang

Investigators

• Principal Investigator: Yongchang Zhang, MD, Hunan Province Tumor Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yongchang Zhang, Professor, Hunan Province Tumor Hospital
• ClinicalTrials.gov Identifier: NCT04144569
• Other Study ID Numbers: POETHIS
• First Posted: Oct 30, 2019
• Last Update Posted: Mar 2, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 2, 2022