Real-World Study on Gene Profile in Patients With Advanced NSCLC Who Progressed on First-Line Osimertinib Therapy(GPS).
GPS
Gene Profile in EGFRm Locally Advanced or Metastatic NSCLC Patients Post Osimertinib 1L Treatment Failure: A Real-world, Multi-center Study (GPS)
1 other identifier
interventional
182
1 country
16
Brief Summary
Although some small sample studies have reported the possible resistance mechanisms of Osimertinib in the first-line treatment, it is still an urgent need to explore the whole gene profile in EGFRm advanced NSCLC patients post Osimertinib 1L treatment by paired tissue and plasma to guide subsequent treatment strategy. Thus, the gene profile post Osimertinib 1L treatment in tissue and plasma may help to guide the following treatment. Participants will be required to provide paired tissue and whole blood after disease progression following 1L Osimertinib. 200 tissue samples and 200 whole blood samples will be used to detect gene alteration by NGS, respectively. 200 tissue samples will be used to detect pathological transformation by IHC. Approximately 80-100 tissue samples will be used to test MET overexpression by MET IHC and MET amplification by FISH respectively. Approximately 80-100 whole blood samples will be used to test MET amplification by ddPCR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2022
Typical duration for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2022
CompletedStudy Start
First participant enrolled
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2024
CompletedResults Posted
Study results publicly available
September 11, 2025
CompletedSeptember 11, 2025
August 1, 2025
2.2 years
December 21, 2021
April 15, 2025
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Gene Alterations inTissue Detected by NGS
The Percentage of gene alteration detected by NGS(%) = (number of patients with gene alteration detected by NGS)/(total number of patients in the FAS)×100%.
At enrollment
Secondary Outcomes (6)
Percentage of Participants With Gene Alterations in Plasma Detected by NGS
At enrollment
EGFR Sensitivity of Plasma and Tissue
At enrollment
EGFR Specificity of Plasma and Tissue
At enrollment
EGFR PPV of Plasma and Tissue
At enrollment
EGFR NPV of Plasma and Tissue
At enrollment
- +1 more secondary outcomes
Study Arms (1)
EGFRm Locally Advanced or Metastatic NSCLC patients post Osimertinib 1L treatment failure
OTHERparticipants with advanced or metastatic non-small cell lung cancer, who have already taken osimertinib as a first treatment option, but their cancer has continued to get worse
Interventions
The tissue and blood sample for this genetic research will be obtained from the participants at baseline(disease progression after 1L Osimertinib). Paired tissue and whole blood sample should be collected per participant for genetics during the study.
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Informed Consent
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Provision of signed and dated, written informed consent form prior to any mandatory study-specific procedures, sampling, and analyses.
- The ICF process is described in Appendix A3., Sex and Age
- Male or female, age at least 18 years. Type of Participant and Disease Characteristics
- Pathologically confirmed non-small cell lung cancer (NSCLC) with documented EGFR sensitive mutation (EGFR 19del and L858R) positive before Osimertinib 1L.
- Locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC(clinical stage IVA or IVB) or recurrent NSCLC (per Version 8 of the International Association for the Study of Lung Cancer \[IASLC\] Staging Manual in Thoracic Oncology), not amenable to curative or radiotherapy (e.g., this may occur as systemic recurrence after prior surgery for early stage disease or patients may be newly diagnosed with stage IIIB/IV disease, which is at the start of Osimertinib therapy).
- Patients must have been treated with Osimertinib as first line therapy until disease progression. Evidence of disease progression following 1L Osimertinib can be confirmed by investigators with criteria in Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.
- Agree to provide adequate tissue and whole blood for testing after disease progression following 1L Osimertinib.
- Reproduction
- Female participants who are not abstinent (in line with the preferred and usual lifestyle choice of the participant) and intend to be sexually active with a male partner must be using highly effective contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to the enrolment or must have evidence of non-child-bearing potential by fulfilling 1 of the following criteria at screening:
- Post-menopausal, defined as more than 50 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be considered as postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- +1 more criteria
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Medical Conditions
- Any concurrent and/or other active malignancy that may affect tissue or whole blood testing results.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, which in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol,. Screening for chronic conditions is not required.
- Prior/Concomitant Therapy
- Any concurrent anticancer treatment except local radiotherapy and radiotherapy for CNS metastasis. Concurrent use of hormonal therapy for non cancer related conditions (eg, hormone replacement therapy) is allowed.
- Prior/Concurrent Clinical Study Experience 5 Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Prior allogeneic bone marrow transplant
- Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (16)
Research Site
Beijing, 100210, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610014, China
Research Site
Dalian, 116023, China
Research Site
Foshan, 528000, China
Research Site
Fuzhou, 350014, China
Research Site
Harbin, 150081, China
Research Site
Hefei, 230001, China
Research Site
Hefei, 230601, China
Research Site
Linhai, 317000, China
Research Site
Luoyang, 471003, China
Research Site
Rizhao, 276826, China
Research Site
Shanghai, 200032, China
Research Site
Taizhou, 225300, China
Research Site
Tianjin, 300060, China
Research Site
Zhengzhou, 450000, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Yuankai Shi, PhD
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2021
First Posted
February 1, 2022
Study Start
February 25, 2022
Primary Completion
April 29, 2024
Study Completion
April 29, 2024
Last Updated
September 11, 2025
Results First Posted
September 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.