Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.

Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI. - Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007817

Enrollment

Registered

2012-05-14

Start date

2012-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer (NSCLC)

Interventions

Detection of mutated EGFR from plasma

gefitinib plus either S-1 or pemetrexed therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven non-small cell lung cancer (NSCLC) 2) Stage IIIB or IV disease 3) NSCLC with EGFR mutation (ex19 deletions or L858R) 4) NSCLC resistant to EGFR-TKI (intrinsic or acquired resistance) 5 ) Previously administered EGFR-TKI over 28 days 6) Undergoing EGFR-TKI monotherapy 7) Aged 20 years or older 8) ECOG performance status 0-2 9) One or more measurable lesions 10) No experience of either S-1 or pemetrexed 11) Experience of platinum use or considered to be ineligible for platinum-based therapy 12) Interval of at least 2 weeks from last surgical procedure or radiation therapy 13) Adequate bone marrow, renal, hepatic and cardiopulmonary function 14) Able to take oral medication 15) Life expectancy of at least 12 weeks 16) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Interstital pneumonitis 2) Uncontrolled intercurrent illness 3) Active infection 4) Need for treatment within 6 months for double cancer 5) Symptomatic CNS metastases 6) Massive pleural effusion or ascites 7) History of irradiation to more than half of pelvic bone 8) Allergy to treatment drugs 9) Pregnant or breast-feeding 10) Unwilling to use adequate contraception 11) Other conditions inadequate for this research

Design outcomes

Primary

Measure	Time frame
Detection rate of mutated EGFR from plasma	—

Secondary

Measure	Time frame
T790M mutation rate, Serum HGF, Progression-free survival (PFS), Toxicities	—

Countries

Japan

Contacts

Public ContactYusuke Takagi

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Department of Thoracic Oncology and Respiratory Medicine

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026