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

NCT04322890 | Recruiting Phase 2

• 1 other identifier: 20200311
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Objective Response Rate (ORR)

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

• Adverse events (AEs) according to CTCAE 5.0

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

• 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

Study Arms (7)

Cohort A: EGFR mutation

EXPERIMENTAL

Lung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc.

Drug: Osimertinib

Cohort B: ALK fusion

EXPERIMENTAL

Lung Cancer with ALK fusion.

Drug: Alectinib 150 MG

Cohort C: ROS1 fusion

EXPERIMENTAL

Lung Cancer with ROS1 fusion.

Drug: Crizotinib 250 MG

Cohort D: MET alterations

EXPERIMENTAL

Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc.

Drug: Savolitinib, Crizotinib.

Cohort E: RET fusion

EXPERIMENTAL

Lung Cancer with RET fusion.

Drug: Chemotherapy

Cohort F: KRAS mutation

EXPERIMENTAL

Lung Cancer with KRAS mutation.

Drug: Chemotherapy

Cohort G: uncommon mutation

EXPERIMENTAL

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.

Drug: Chemotherapy

Interventions

Osimertinib DRUG

Osimertinib 80mg, po, qd;

Also known as: Erlotinib, Gefitinib, Furmonertinib, Almonertinib etc.

Cohort A: EGFR mutation

Alectinib 150 MG DRUG

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

Also known as: Lorlatinib, Alectinib, Brigatinib, Ceritinib etc.

Cohort B: ALK fusion

Crizotinib 250 MG DRUG

Crizotinib 250 MG po bid.

Also known as: Entrectinib

Cohort C: ROS1 fusion

Savolitinib, Crizotinib. DRUG

Savolitinib, 300mg po qd.

Also known as: Crizotinib

Cohort D: MET alterations

Chemotherapy DRUG

500mg, ivgtt, every 21day.

Also known as: Pemetrexed, Cisplatin, Pralsetinib etc.

Cohort E: RET fusion; Cohort F: KRAS mutation; Cohort G: uncommon mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
• Age ≥ 18 years.
• Histologically or cytologically confirmed, Stage IV NSCLC.
• Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc.
• ECOG 0-1.
• Predicted survival ≥ 12 weeks.
• Adequate bone marrow hematopoiesis and organ function
• Presence of measurable lesions according to RECIST 1.1.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Yongchang Zhang

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib; Erlotinib Hydrochloride; Gefitinib; aflutinib; alectinib; lorlatinib; brigatinib; Crizotinib; entrectinib; 1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine; Drug Therapy; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Aminopyridines; Pyridines; Therapeutics; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yongchang Zhang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613055193557; yangnong0217@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Clinical Trial Center

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: April 16, 2020
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 24, 2027
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

CN (1)