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

Phase 2RecruitingNCT04322890

Hunan Province Tumor Hospital6,000 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

6,000

Conditions

Non Small Cell Lung Cancer EGFR Gene Mutation ALK Gene Mutation ROS1 Gene Mutation MET Gene Mutation

Interventions

OsimertinibDRUG

Osimertinib 80mg, po, qd;

Alectinib 150 MGDRUG

Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd;

Crizotinib 250 MGDRUG

Crizotinib 250 MG po bid.

Savolitinib, Crizotinib.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Yongchang Zhang

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

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 frame: Time from first subject dose to study completion, or up to 36 month

Secondary Outcomes

Overall survival (OS)

To assess overall survival, define as first dose to the death of the subject due to any cause

Time frame: To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years

Objective Response Rate (ORR)

Time frame: Time from first subject dose to study completion, or up to 36 month

Adverse events (AEs) according to CTCAE 5.0

Number of participants with adverse events (AEs) according to CTCAE 5.0

Time frame: From first dose until 28 days after the last dose, up to 24 month

Patient reported outcome (PRO)

Patient reported outcome defined as the quality of life during the whole process treatment.

Time frame: To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years

Central Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436 zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613055193557 yangnong0217@163.com

Data from ClinicalTrials.gov

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