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Advanced NSCLCPhase 4GPSNCT05219162

Real-World Study on Gene Profile in Patients With Advanced NSCLC Who Progressed on First-Line Osimertinib Therapy(GPS).

A Phase 4 study testing Gene Profile explore in people with Advanced NSCLC, run by AstraZeneca at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 86 years
Conditions the study is for
Advanced NSCLC
What is being tested?
Gene Profile explore
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
16 sitesChina
Study dates
25 Feb 2022to 29 Apr 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 86 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 28Show fewer
  • 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.
  • Further information is available in Appendix E (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods).
  • Male participants must be willing to use barrier contraception. Exclusion Criteria
  • 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.
  • Other Exclusions 6 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • 7 In addition, the following are considered criteria for exclusion from the exploratory genetic research:
  • Prior allogeneic bone marrow transplant
  • Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection.

Who cannot join

None listed.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Research Site

    Beijing, 100210

  • Research Site

    Changsha, 410013

  • Research Site

    Chengdu, 610014

  • Research Site

    Dalian, 116023

  • Research Site

    Foshan, 528000

  • Research Site

    Fuzhou, 350014

  • Research Site

    Harbin, 150081

  • Research Site

    Hefei, 230001

  • Research Site

    Hefei, 230601

  • Research Site

    Linhai, 317000

  • Research Site

    Luoyang, 471003

  • Research Site

    Rizhao, 276826

  • Research Site

    Shanghai, 200032

  • Research Site

    Taizhou, 225300

  • Research Site

    Tianjin, 300060

  • Research Site

    Zhengzhou, 450000

Other trials in China

About this study

Official title: Gene Profile in EGFRm Locally Advanced or Metastatic NSCLC Patients Post Osimertinib 1L Treatment Failure: A Real-world, Multi-center Study (GPS)

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.

Read the detailed description

"Tumor tissue samples will be obtained by biopsy."

Conditions
Advanced NSCLC
Being tested
Gene Profile explore
Keywords
Advanced or metastatic non-small cell lung cancer
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.

  • Gene Profile exploreGenetic

    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.

Study groups in NCT05219162
Study groupRoleWhat they receive
EGFRm Locally Advanced or Metastatic NSCLC patients post Osimertinib 1L treatment failureOtherparticipants 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
Receives: Genetic: Gene Profile explore

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: At enrollment

Secondary outcomes (6)

  1. Percentage of Participants With Gene Alterations in Plasma 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%.

    Measured: At enrollment

  2. EGFR Sensitivity of Plasma and Tissue

    Tissue sample was the reference standard.

    -sensitivity=(number of patients with positive result in both plasma and tissue)/(total number of patients with positive result in tissue samples)×100%

    Measured: At enrollment

  3. EGFR Specificity of Plasma and Tissue

    Tissue sample was the reference standard.

    • specificity=(number of patients with negative result in both plasma and tissue)/(total number of patients with negative result in tissue samples)×100%.

    Measured: At enrollment

  4. EGFR PPV of Plasma and Tissue

    Tissue sample was the reference standard. PPV (%)=(number of patients with positive result in both plasma and tissue)/(total number of patients with positive result in plasma samples)×100%

    Measured: At enrollment

  5. EGFR NPV of Plasma and Tissue

    Tissue sample was the reference standard.

    • NPV (%)=(number of patients with negative result in both plasma and tissue)/(total number of patients with negative result in plasma samples)×100%.

    Measured: At enrollment

  6. The Percentage of Pathology Transformation

    Pathology transformation was defined as those transformation from non-small-cell lung cancer to small-cell lung cancer or from adenocarcinoma to squamous carcinoma, can be observed by IHC Proportion of pathology transformation(%) = (number of patients with pathology transformation)/(total number of patients in the FAS)×100%.

    Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start25 Feb 2022
  3. Primary completion29 Apr 2024
  4. Study completion29 Apr 2024

Resources

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 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05219162
Sponsor's protocol ID
D5161R00037
Acronym
GPS
Status last verified
Aug 2025
First submitted
21 Dec 2021
Last updated
11 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Shi Y, Lv D, Feng W, Liu S, Xing P, Yu Y, Yin J, Ren X, Zhang J, Han G, Zhang Y, Cang S, Chen J, Chen E, Meng L, Zhang Y. A prospective, multicenter, comprehensive genomic profile signature study in patients with EGFR-mutant advanced non-small cell lung cancer at the first-line treatment failure of osimertinib. Signal Transduct Target Ther. 2025 Dec 2;10(1):393. doi: 10.1038/s41392-025-02481-8.

    PubMed 41326340

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gene Profile explore in people with Advanced NSCLC, run by AstraZeneca at 16 sites 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 28 inclusion and 0 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: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Gene Alterations inTissue Detected by NGS (time frame: At enrollment). 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 NCT05219162, 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 11 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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