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NCT Number: NCT04322890

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.

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Key information

Conditions

Non Small Cell Lung Cancer ALK Gene Mutation Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung EGFR Gene Mutation Lung Diseases Lung Neoplasms MET Gene Mutation Neoplasms Neoplasms by Site ROS1 Gene Mutation Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yongchang Zhang

Changsha, Hunan, 410013, China

Location status: Recruiting

Location contact

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. +8613873123436

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

The patient did not match from the Inclusion Criteria.

Treatment and study plan

Osimertinib

Drug

Osimertinib 80mg, po, qd;

Other names: Erlotinib, Gefitinib, Furmonertinib, Almonertinib etc.

Alectinib 150 MG

Drug

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

Other names: Lorlatinib, Alectinib, Brigatinib, Ceritinib etc.

Crizotinib 250 MG

Drug

Crizotinib 250 MG po bid.

Other names: Entrectinib

Savolitinib, Crizotinib.

Drug

Savolitinib, 300mg po qd.

Other names: Crizotinib

Chemotherapy

Drug

500mg, ivgtt, every 21day.

Other names: Pemetrexed, Cisplatin, Pralsetinib etc.

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 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 outcomes

  1. Overall survival (OS)

    Time frame: 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

  2. Objective Response Rate (ORR)

    Time frame: 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.

  3. Adverse events (AEs) according to CTCAE 5.0

    Time frame: 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

  4. Patient reported outcome (PRO)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Yang, MD

CONTACT

[email protected]

+8613055193557 ext. +8613873123436

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. 7+861383123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Acronym: PIKACHU

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Mar 26, 2020
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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