Trial Outcomes & Findings for Real-World Study on Gene Profile in Patients With Advanced NSCLC Who Progressed on First-Line Osimertinib Therapy(GPS). (NCT NCT05219162)

Results Overview

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%.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

182 participants

Primary outcome timeframe

At enrollment

Results posted on

2025-09-11

Participant Flow

The study screened the first participant on 25 February 2022 and the last participant's last visit was completed on 29 April 2024. A total of 183 participants were screened (signed ICF), among which, 182 participants (99.5%) were successfully enrolled into the study from 16 study sites in China

Among the 183 screened (signed ICF) participants, 182 of them (99.5%) successfully enrolled in the study (fulfilled eligibility criteria at screening), while only 1 participant (0.5%) did not meet the inclusion criteria. A total of 149 subjects who had valid gene data from both plasma and tissue were included in the Full Analysis Set (FAS), which will be the primary analysis set for all analyses.

Participant milestones

Participant milestones
Measure	Patients With EGFR Negative Result in Plasma Samples patients with EGFR negative result in plasma samples
Overall Study STARTED	182
Overall Study Full Analysis Set	149
Overall Study COMPLETED	153
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With EGFR Negative Result in Plasma Samples patients with EGFR negative result in plasma samples
Overall Study Meet exclusion criterion or did not meet inclusion criteria	6
Overall Study Withdrawal by Subject	23

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With EGFR Negative Result in Plasma Samples n=149 Participants patients with EGFR negative result in plasma samples
Age, Continuous Age(years)	62.3 years STANDARD_DEVIATION 9.98 • n=5 Participants
Sex: Female, Male Sex · Female	84 Participants n=5 Participants
Sex: Female, Male Sex · Male	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	149 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At enrollment

Population: 149 subjects who had valid gene data from both plasma and tissue were included in the analysis.

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%.

Outcome measures

Outcome measures
Measure	Post Osimertinib 1L Treatment n=149 Participants Post Osimertinib first-line (1L) treatment
Percentage of Participants With Gene Alterations inTissue Detected by NGS EGFR	139 Participants
Percentage of Participants With Gene Alterations inTissue Detected by NGS TP53	106 Participants
Percentage of Participants With Gene Alterations inTissue Detected by NGS MET	47 Participants

SECONDARY outcome

Timeframe: At enrollment

Population: 149 subjects who had valid gene data from both plasma and tissue were included in the analysis.

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%.

Outcome measures

Outcome measures
Measure	Post Osimertinib 1L Treatment n=149 Participants Post Osimertinib first-line (1L) treatment
Percentage of Participants With Gene Alterations in Plasma Detected by NGS EGFR	115 Participants
Percentage of Participants With Gene Alterations in Plasma Detected by NGS TP53	65 Participants
Percentage of Participants With Gene Alterations in Plasma Detected by NGS MET	14 Participants

SECONDARY outcome

Timeframe: At enrollment

Population: 139 Patients with EGFR positive in 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%

Outcome measures

Outcome measures
Measure	Post Osimertinib 1L Treatment n=139 Participants Post Osimertinib first-line (1L) treatment
EGFR Sensitivity of Plasma and Tissue	113 Participants

SECONDARY outcome

Timeframe: At enrollment

Population: 10 patients with negative result in tissue samples

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%.

Outcome measures

Outcome measures
Measure	Post Osimertinib 1L Treatment n=10 Participants Post Osimertinib first-line (1L) treatment
EGFR Specificity of Plasma and Tissue	8 Participants

SECONDARY outcome

Timeframe: At enrollment

Population: 115 patients with positive result in plasma samples

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%

Outcome measures

Outcome measures
Measure	Post Osimertinib 1L Treatment n=115 Participants Post Osimertinib first-line (1L) treatment
EGFR PPV of Plasma and Tissue	113 Participants

SECONDARY outcome

Timeframe: At enrollment

Population: 34 patients with negative result in plasma samples

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%.

Outcome measures

Outcome measures
Measure	Post Osimertinib 1L Treatment n=34 Participants Post Osimertinib first-line (1L) treatment
EGFR NPV of Plasma and Tissue	8 Participants

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome measures
Measure	Post Osimertinib 1L Treatment n=149 Participants Post Osimertinib first-line (1L) treatment
The Percentage of Pathology Transformation Non-small-cell lung cancer to small-cell lung cancer	2 Participants
The Percentage of Pathology Transformation Adenocarcinoma to squamous carcinoma	2 Participants

Adverse Events

Patients With EGFR Negative Result in Plasma Samples

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place