Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation

Non Small Cell Lung Cancer Clinical Trial

— PIKACHU  

Official title:

Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322890
• Other study ID #: 20200311
• Status: Recruiting
• Phase: Phase 2
• Start date: April 16, 2020
• Est. completion date: December 24, 2027

Study information

• Verified date: June 2024
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.

Description:

The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation. Our study was set up with several group with EGFR mutant, ALK fusion, ROS1 fusion, RET fusion, BRAF mutation, NRG1 fusion, MET alteration, KRAS mutation, etc.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 24, 2027
• Est. primary completion date: December 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.

2. Age = 18 years.

3. Histologically or cytologically confirmed, Stage IV NSCLC.

4. Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc.

5. ECOG 0-1.

6. Predicted survival = 12 weeks.

7. Adequate bone marrow hematopoiesis and organ function

8. Presence of measurable lesions according to RECIST 1.1. Exclusion Criteria: The patient did not match from the Inclusion Criteria.

Related Conditions & MeSH terms

• ALK Gene Mutation
• Carcinoma, Non-Small-Cell Lung
• EGFR Gene Mutation
• Lung Neoplasms
• MET Gene Mutation
• Non Small Cell Lung Cancer
• ROS1 Gene Mutation

Intervention

Drug:
• Osimertinib
Osimertinib 80mg, po, qd;
• Alectinib 150 MG
Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd;
• Crizotinib 250 MG
Crizotinib 250 MG po bid.
• Savolitinib, Crizotinib.
Savolitinib, 300mg po qd.
• Chemotherapy
500mg, ivgtt, every 21day.

Locations

Country	Name	City	State
China	Yongchang Zhang	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	To assess progression-free survival of patients treated with target treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause.	Time from first subject dose to study completion, or up to 36 month
Secondary	Overall survival (OS)	To assess overall survival, define as first dose to the death of the subject due to any cause	To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years
Secondary	Objective Response Rate (ORR)	To assess progression-free survival of patients treated with target treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause.	Time from first subject dose to study completion, or up to 36 month
Secondary	Adverse events (AEs) according to CTCAE 5.0	Number of participants with adverse events (AEs) according to CTCAE 5.0	From first dose until 28 days after the last dose, up to 24 month
Secondary	Patient reported outcome (PRO)	Patient reported outcome defined as the quality of life during the whole process treatment.	To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years