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

Phase 2

Recruiting

• Conditions: MET Gene Mutation; Non Small Cell Lung Cancer; ALK Gene Mutation; ROS1 Gene Mutation; EGFR Gene Mutation
• Interventions: Drug: Osimertinib; Drug: Alectinib 150 MG; Drug: Crizotinib 250 MG; Drug: Savolitinib, Crizotinib.; Drug: Chemotherapy

• Registration Number: NCT04322890
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Study Start: 2020-04-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22
• Primary Completion: 2026-12-24
• Study Completion: 2027-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A: EGFR mutation	Osimertinib	Lung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc.
Cohort B: ALK fusion	Alectinib 150 MG	Lung Cancer with ALK fusion.
Cohort C: ROS1 fusion	Crizotinib 250 MG	Lung Cancer with ROS1 fusion.
Cohort D: MET alterations	Savolitinib, Crizotinib.	Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc.
Cohort E: RET fusion	Chemotherapy	Lung Cancer with RET fusion.
Cohort F: KRAS mutation	Chemotherapy	Lung Cancer with KRAS mutation.
Cohort G: uncommon mutation	Chemotherapy	Cohort G mainly includes all identified lung cancer mutations except EGFR mut, ALK fusion, ROS1 fusion, MET alterations, KRAS mut and RET fusion. These include: BRAF V600E and non-V600E, NRG fusion, NTRK fusion, ERBB2 amp and mut，NRAS mut, MAP2K1 mut，RIT1 mut, RAF1 mut, FGFR fusion, ARAF mut, HRAS mut etc.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Time from first subject dose to study completion, or up to 36 month	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs) according to CTCAE 5.0	From first dose until 28 days after the last dose, up to 24 month	Number of participants with adverse events (AEs) according to CTCAE 5.0
Patient reported outcome (PRO)	To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years	Patient reported outcome defined as the quality of life during the whole process treatment.
Overall survival (OS)	To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years	To assess overall survival, define as first dose to the death of the subject due to any cause
Objective Response Rate (ORR)	Time from first subject dose to study completion, or up to 36 month	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.

Trial Locations

Locations (1)

Yongchang Zhang; 🇨🇳 Changsha, Hunan, China