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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 6000
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nong Yang, MD; Phone Number: +8613873123436 +8613055193557; Email: yangnong0217@163.com
• Study Contact Backup: Name: Yongchang Zhang, MD; Phone Number: 7+861383123436 +8613873123436; Email: zhangyongchang@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Yongchang Zhang
      • Contact: Yongchang Zhang, MD; Phone Number: +8613873123436 +8613873123436; Email: zhangyongchang@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

TKI Failure EGFR/ALK/ROS1 mutation positive advanced Non-small cell lung cancer

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: EGFR mutation; Lung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc.	Drug: Osimertinib; Osimertinib 80mg, po, qd; Other Names: Erlotinib, Gefitinib, Furmonertinib, Almonertinib etc.
Experimental: Cohort B: ALK fusion; Lung Cancer with ALK fusion.	Drug: Alectinib 150 MG; Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd; Other Names: Lorlatinib, Alectinib, Brigatinib, Ceritinib etc.
Experimental: Cohort C: ROS1 fusion; Lung Cancer with ROS1 fusion.	Drug: Crizotinib 250 MG; Crizotinib 250 MG po bid.; Other Names: Entrectinib
Experimental: Cohort D: MET alterations; Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc.	Drug: Savolitinib, Crizotinib.; Savolitinib, 300mg po qd.; Other Names: Crizotinib
Experimental: Cohort E: RET fusion; Lung Cancer with RET fusion.	Drug: Chemotherapy; 500mg, ivgtt, every 21day.; Other Names: Pemetrexed, Cisplatin; Pralsetinib etc.
Experimental: Cohort F: KRAS mutation; Lung Cancer with KRAS mutation.	Drug: Chemotherapy; 500mg, ivgtt, every 21day.; Other Names: Pemetrexed, Cisplatin; Pralsetinib etc.
Experimental: Cohort G: uncommon mutation; 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; 500mg, ivgtt, every 21day.; Other Names: Pemetrexed, Cisplatin; Pralsetinib etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 24, 2027

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 19, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Protein Kinase Inhibitors; Gefitinib; Osimertinib; Pemetrexed; Crizotinib; Pralsetinib; Entrectinib; Cisplatin; Ceritinib; Alectinib
• Other Study ID Numbers: 20200311

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No