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

Hunan Province Tumor Hospital

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Alectinib 150 MG; Drug: Crizotinib 250 MG; Drug: Savolitinib, Crizotinib.; Drug: Osimertinib; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04322890

20200311

Details and patient eligibility

About

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

Full 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,000 participants in 7 patient groups

Cohort A: EGFR mutation

Experimental group

Description:

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

Treatment:

Drug: Osimertinib

Cohort B: ALK fusion

Experimental group

Description:

Lung Cancer with ALK fusion.

Treatment:

Drug: Alectinib 150 MG

Cohort C: ROS1 fusion

Experimental group

Description:

Lung Cancer with ROS1 fusion.

Treatment:

Drug: Crizotinib 250 MG

Cohort D: MET alterations

Experimental group

Description:

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

Treatment:

Drug: Savolitinib, Crizotinib.

Cohort E: RET fusion

Experimental group

Description:

Lung Cancer with RET fusion.

Treatment:

Drug: Chemotherapy

Cohort F: KRAS mutation

Experimental group

Description:

Lung Cancer with KRAS mutation.

Treatment:

Drug: Chemotherapy

Cohort G: uncommon mutation

Experimental group

Description:

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.

Treatment:

Drug: Chemotherapy