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

COMPLETEDPHASE4

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

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

NCT05219162•AstraZeneca

View on ClinicalTrials.gov

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.

Detailed Description

"Tumor tissue samples will be obtained by biopsy."

Eligibility

Age

18 - 86 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply:
•Informed Consent
•1. 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.
•2. 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
•3. Male or female, age at least 18 years. Type of Participant and Disease Characteristics
•4. Pathologically confirmed non-small cell lung cancer (NSCLC) with documented EGFR sensitive mutation (EGFR 19del and L858R) positive before Osimertinib 1L.
•5. 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).
•6. 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.
•7. Agree to provide adequate tissue and whole blood for testing after disease progression following 1L Osimertinib.
+6 more criteria

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•Medical Conditions
•1. Any concurrent and/or other active malignancy that may affect tissue or whole blood testing results.
•2. 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
•3. 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
+1 more criteria

Locations (16)

Research Site

Beijing, China

Research Site

Changsha, China

Research Site

Chengdu, China

Research Site

Dalian, China

Research Site

Foshan, China

Research Site

Fuzhou, China

Research Site

Harbin, China

Research Site

Hefei, China

Research Site

Hefei, China

Research Site

Linhai, China

Key Dates

Start Date

February 25, 2022

Primary Completion Date

April 29, 2024

Completion Date

April 29, 2024

Last Updated

September 11, 2025

Enrollment

182

ACTUAL participants

Conditions

Advanced NSCLC

Interventions

Gene Profile explore

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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