Non Small Cell Lung CancerPhase 2PIKACHUNCT04322890
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation
A Phase 2 study testing Osimertinib, Alectinib 150 MG and Crizotinib 250 MG in people with Non Small Cell Lung Cancer and EGFR Gene Mutation, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation
- What is being tested?
- Osimertinib, Alectinib 150 MG and Crizotinib 250 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2020to 24 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The patient did not match from the Inclusion Criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yongchang Zhang
Changsha, Hunan, 410013
Yongchang Zhang, MD, +8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation, ROS1 Gene Mutation, MET Gene Mutation
- Being tested
- Osimertinib, Alectinib 150 MG, Crizotinib 250 MG, Savolitinib, Crizotinib., Chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called Erlotinib, Gefitinib, Furmonertinib, Almonertinib etc.
Osimertinib 80mg, po, qd;
Alectinib 150 MGDrug
Also called Lorlatinib, Alectinib, Brigatinib, Ceritinib etc.
Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd;
Crizotinib 250 MGDrug
Also called Entrectinib
Crizotinib 250 MG po bid.
Savolitinib, Crizotinib.Drug
Also called Crizotinib
Savolitinib, 300mg po qd.
ChemotherapyDrug
Also called Pemetrexed, Cisplatin, Pralsetinib etc.
500mg, ivgtt, every 21day.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: EGFR mutation | Experimental | Lung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc. Receives: Drug: Osimertinib |
| Cohort B: ALK fusion | Experimental | Lung Cancer with ALK fusion. Receives: Drug: Alectinib 150 MG |
| Cohort C: ROS1 fusion | Experimental | Lung Cancer with ROS1 fusion. Receives: Drug: Crizotinib 250 MG |
| Cohort D: MET alterations | Experimental | Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc. Receives: Drug: Savolitinib, Crizotinib. |
| Cohort E: RET fusion | Experimental | Lung Cancer with RET fusion. Receives: Drug: Chemotherapy |
| Cohort F: KRAS mutation | Experimental | Lung Cancer with KRAS mutation. Receives: 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. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs) according to CTCAE 5.0
Number of participants with adverse events (AEs) according to CTCAE 5.0
Measured: From first dose until 28 days after the last dose, up to 24 month
Patient reported outcome (PRO)
Patient reported outcome defined as the quality of life during the whole process treatment.
Measured: To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start16 Apr 2020
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322890
- Sponsor's protocol ID
- 20200311
- Acronym
- PIKACHU
- Status last verified
- Oct 2024
- First submitted
- 24 Mar 2020
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
- ClinicalTrials.gov ID
- NCT04322890
- Acronym / sponsor ID
- PIKACHU / 20200311
- Conditions
- Non Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation, ROS1 Gene Mutation, MET Gene Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2027 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A: EGFR mutation | Experimental | Drug: OsimertinibLung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc. |
| Cohort B: ALK fusion | Experimental | Drug: Alectinib 150 MGLung Cancer with ALK fusion. |
| Cohort C: ROS1 fusion | Experimental | Drug: Crizotinib 250 MGLung Cancer with ROS1 fusion. |
| Cohort D: MET alterations | Experimental | Drug: Savolitinib, Crizotinib.Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc. |
| Cohort E: RET fusion | Experimental | Drug: ChemotherapyLung Cancer with RET fusion. |
| Cohort F: KRAS mutation | Experimental | Drug: ChemotherapyLung Cancer with KRAS mutation. |
| Cohort G: uncommon mutation | Experimental | Drug: ChemotherapyCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- The patient did not match from the Inclusion Criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsimertinibAlso: Erlotinib, Gefitinib, Furmonertinib, Almonertinib etc.Osimertinib 80mg, po, qd; | Drug | Cohort A: EGFR mutation |
| Alectinib 150 MGAlso: Lorlatinib, Alectinib, Brigatinib, Ceritinib etc.Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd; | Drug | Cohort B: ALK fusion |
| Crizotinib 250 MGAlso: EntrectinibCrizotinib 250 MG po bid. | Drug | Cohort C: ROS1 fusion |
| Savolitinib, Crizotinib.Also: CrizotinibSavolitinib, 300mg po qd. | Drug | Cohort D: MET alterations |
| ChemotherapyAlso: Pemetrexed, Cisplatin, Pralsetinib etc.500mg, ivgtt, every 21day. | Drug | Cohort E: RET fusion, Cohort F: KRAS mutation, Cohort G: uncommon mutation |
Primary outcome
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.
4 secondary outcomes
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
Objective Response Rate (ORR)
Time frame: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs) according to CTCAE 5.0
Time frame: From first dose until 28 days after the last dose, up to 24 month
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongchang Zhang, MD principal investigator
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osimertinib, Alectinib 150 MG and Crizotinib 250 MG in people with Non Small Cell Lung Cancer and EGFR Gene Mutation, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongchang Zhang, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Time from first subject dose to study completion, or up to 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.