NCT05219162: GPS

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

Completed Phase 4 Results posted Last updated 11 September 2025

What this trial tests

Phase 4 trial testing Gene Profile explore in Advanced NSCLC in 182 participants. Completed in 29 April 2024.

Timeline

25 February 2022

Primary endpoint
29 April 2024

29 April 2024

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	182
Start date	25 February 2022
Primary completion	29 April 2024
Estimated completion	29 April 2024
Sites	16 locations across China

Drugs / interventions tested

• Gene Profile explore

Conditions studied

• Advanced NSCLC — all drugs for Advanced NSCLC →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 86, any sex, with Advanced NSCLC. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Gene Alterations inTissue Detected by NGS Primary · At enrollment

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%.

EGFR

Group	Value	95% CI
Post Osimertinib 1L Treatment	139

TP53

Group	Value	95% CI
Post Osimertinib 1L Treatment	106

MET

Group	Value	95% CI
Post Osimertinib 1L Treatment	47

Percentage of Participants With Gene Alterations in Plasma Detected by NGS Secondary · At enrollment

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%.

EGFR

Group	Value	95% CI
Post Osimertinib 1L Treatment	115

TP53

Group	Value	95% CI
Post Osimertinib 1L Treatment	65

MET

Group	Value	95% CI
Post Osimertinib 1L Treatment	14

EGFR Sensitivity of Plasma and Tissue Secondary · At enrollment

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%

Group	Value	95% CI
Patients With EGFR Positive in Tissue	113

EGFR Specificity of Plasma and Tissue Secondary · At enrollment

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%.

Group	Value	95% CI
Patients With EGFR Negative Result in Tissue Samples	8

EGFR PPV of Plasma and Tissue Secondary · At enrollment

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%

Group	Value	95% CI
Patients With EGFR Positive Result in Plasma Samples	113

EGFR NPV of Plasma and Tissue Secondary · At enrollment

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%.

Group	Value	95% CI
Patients With EGFR Negative Result in Plasma Samples	8

The Percentage of Pathology Transformation Secondary · At enrollment

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%.

Non-small-cell lung cancer to small-cell lung cancer

Group	Value	95% CI
Post Osimertinib 1L Treatment	2

Adenocarcinoma to squamous carcinoma

Group	Value	95% CI
Post Osimertinib 1L Treatment	2

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Shi Y, Lv D, Feng W, Liu S, et al · · 2025 · PMID 41326340 · DOI 10.1038/s41392-025-02481-8
2. Update on the Treatment of Non-Small Cell Lung Carcinoma (NSCLC).
   Kariri YA. · · 2025 · PMID 41096039 · DOI 10.3390/jcm14196960
3. Phase IV clinical trials for the treatment of non-small cell lung carcinoma (NSCLC): A systemic review from 2020-2025.
   Kariri YA, Alqasmi MH, Alqahtani BS. · · 2025 · PMID 41087063 · DOI 10.15537/smj.2025.46.10.20250385