EGFR T790MPhase 2NCT05458726
Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via ddPCR in NSCLC
A Phase 2 study testing Osimertinib in people with EGFR T790M and Osimertinib, run by Peking Union Medical College at 1 site in China.
Trial summary
Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- EGFR T790M, Osimertinib, Non-small Cell Lung Cancer
- What is being tested?
- Osimertinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2020to 31 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically/cytologically confirmed stage IV NSCLC patients harboring sensitizing EGFR mutations;
- progression from first or second-generation EGFR-TKI confirmed by radiographic imaging;
- received both NGS test and ddPCR from peripheral blood simultaneously.
Who cannot join
- progression from first- or second-generation EGFR-TKIs as adjuvant therapy;
- having received third-generation EGFR-TKIs prior to the gene tests;
- having received NGS test only or ddPCR test only.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Junling Li
Beijing, Beijing Municipality, 100021
Junling Li, Doctor, +86 13801178891, lijunling@cicams.ac.cn
About this study
Official title: Research on the Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via Digital Droplet PCR (ddPCR) From Peripheral Blood in NSCLC Patients
Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Liquid biopsy methods for detecting T790M in ctDNA can be qualitative or quantitative, including amplification refractory mutation system PCR (ARMS-PCR), digital droplet polymerase chain reaction (ddPCR), and next generation sequencing (NGS)-based methods. Comparison of multiple detecting platform for EGFR mutations in plasma samples has been undertaken in studies to determine the most feasible assay in clinical practice. In this study, we will investigate the usefulness of ddPCR for quantitative detection of EGFR T790M mutation in peripheral blood, and compared the utility of ddPCR and NGS for guiding decisions regarding osimertinib therapy in NSCLC patients who had develop resistance to first- or second generation EGFR-TKIs.
- Conditions
- EGFR T790M, Osimertinib, Non-small Cell Lung Cancer, ddPCR
- Being tested
- Osimertinib
- 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 paclitaxel, carboplatin, pemetrexed
Osimertinib or chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib | Experimental | Osimertinib 80mg po daily Receives: Drug: Osimertinib |
| Other treatments | Sham comparator | chemotherapy or continuation of TKI monotherapy or in combination of anti-angiogenic agents Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause
Measured: up to 1 year
Secondary outcomes (2)
ORR
the sum of CR and PR rates
Measured: up to 1 year
DCR
the sum of CR ,PR and SD rates
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start15 Sep 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EGFR T790MStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junling Li, Peking Union Medical College
- Investigators
- Junling Li, Professor, Principal investigator, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458726
- Sponsor's protocol ID
- NCC-005374
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu Z, Li Y, Wang L, Hao X, Ying J, Li J, Xing P. Efficacy of third-generation epidermal growth factor receptor-tyrosine kinase inhibitors in advanced NSCLC with different T790M statuses tested via digital droplet polymerase chain reaction ddPCR and next-generation sequencing. Expert Rev Anticancer Ther. 2024 Mar-Apr;24(3-4):183-192. doi: 10.1080/14737140.2024.2334807. Epub 2024 Apr 17.
PubMed 38526910
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via Digital Droplet PCR (ddPCR) From Peripheral Blood in NSCLC Patients
- ClinicalTrials.gov ID
- NCT05458726
- Acronym / sponsor ID
- NCC-005374
- Conditions
- EGFR T790M, Osimertinib, Non-small Cell Lung Cancer, ddPCR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 14 Jul 2022 (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.
Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Liquid biopsy methods for detecting T790M in ctDNA can be qualitative or quantitative, including amplification refractory mutation system PCR (ARMS-PCR), digital droplet polymerase chain reaction (ddPCR), and next generation sequencing (NGS)-based methods. Comparison of multiple detecting platform for EGFR mutations in plasma samples has been undertaken in studies to determine the most feasible assay in clinical practice. In this study, we will investigate the usefulness of ddPCR for quantitative detection of EGFR T790M mutation in peripheral blood, and compared the utility of ddPCR and NGS for guiding decisions regarding osimertinib therapy in NSCLC patients who had develop resistance to first- or second generation EGFR-TKIs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osimertinib | Experimental | Drug: OsimertinibOsimertinib 80mg po daily |
| Other treatments | Sham comparator | Drug: Osimertinibchemotherapy or continuation of TKI monotherapy or in combination of anti-angiogenic agents |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histologically/cytologically confirmed stage IV NSCLC patients harboring sensitizing EGFR mutations;
- progression from first or second-generation EGFR-TKI confirmed by radiographic imaging;
- received both NGS test and ddPCR from peripheral blood simultaneously.
Key exclusion criteria (3 listed)
- progression from first- or second-generation EGFR-TKIs as adjuvant therapy;
- having received third-generation EGFR-TKIs prior to the gene tests;
- having received NGS test only or ddPCR test only.
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: paclitaxel, carboplatin, pemetrexedOsimertinib or chemotherapy | Drug | Osimertinib, Other treatments |
Primary outcome
PFS
Time frame: up to 1 year
Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause
2 secondary outcomes
ORR
Time frame: up to 1 year
DCR
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 38526910Xu Z, Li Y, Wang L, Hao X, Ying J, Li J, Xing P. Efficacy of third-generation epidermal growth factor receptor-tyrosine kinase inhibitors in advanced NSCLC with different T790M statuses tested via digital droplet polymerase chain reaction ddPCR and next-generation sequencing. Expert Rev Anticancer Ther. 2024 Mar-Apr;24(3-4):183-192. doi: 10.1080/14737140.2024.2334807. Epub 2024 Apr 17.
- Individual participant dataSharing planned: No
Related trials for EGFR T790M
Active, not recruitingPhase 1
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NSCLC (Advanced Non-small Cell Lung Cancer)
Active, not recruitingObservational study
INHERIT EGFR - Studying Germline EGFR Mutations
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Active, not recruitingPhase 2
Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 4
AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients with EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC
Non-squamous NSCLC
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. This study is not recruiting at the moment.
Junling Li, Professor principal investigator
Chinese Academy of Medical Sciences and Peking Union Medical College
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 in people with EGFR T790M and Osimertinib, run by Peking Union Medical College 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junling Li, Professor (+8613801178891, lijunling@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05458726, which also lists 1 linked publication.
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 26 Jul 2022.