The combination therapy of pemetrexed and continued EGFR-TKIs beyond disease progression to first-line EGFR-TKIs treatments in elderly patients with advanced non-small-cell lung cancer harboring EGFR mutations: a phase 2 trial.

The combination therapy of pemetrexed and continued EGFR-TKIs beyond disease progression to first-line EGFR-TKIs treatments in elderly patients with advanced non-small-cell lung cancer harboring EGFR mutations: a phase 2 trial. - Pemetrexed and continued EGFR-TKIs beyond progressive disease in elderly patients with EGFR-mutant advanced NSCLC.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010935

Enrollment

Registered

2013-06-12

Start date

2013-06-12

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

Interventions

The combination therapy of pemetrexed and continued EGFR-TKIs in elderly patients with EGFR-mutant advanced NSCLC that has developed acquired resistance to EGFR-TKIs is assessed.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All participants must meet the following criteria. 1: Histologically or pathologically proven non-squamous NSCLC. 2: Stage 3B, 4, or recurrence. 3: EGFR mutation positive. 4: Previously treated with EGFR-TKIs more than 8 weeks effectively (SD,PR, or CR), then acquired resistance. 5: Radiographically measurable lesion. 6: Age 75 years or older. 7: Eastern Cooperative Oncology Group (ECOG) performance status: 0-2. 8: No major organ system dysfunction. a. White blood cell count: more than 3,000/uL. b. Neutrophil cell count: more than 1500/uL. c. Hemoglobin: more than 9.0 g/dL. d. Platelet count: more than 100,000/uL. e. Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range. f. Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range. g. Creatinine: less than 1.2 mg/dL. h. Creatinine clearance: more than 45 ml/min. i. SpO2: more than 90%. 9: No interstitial lung disease. 10: Life expectancy of more than 3 months. 11: Written informed.

Exclusion criteria

Exclusion criteria: Exclusion criteria are as follows 1: Symptomatic brain metastasis. 2: History of radiotherapy to primary lesion. 3: Severe and unstable medical comorbidities. 4: Difficulty in ingestion. 5: With third-space fluid to be drained. 6: Pregnant or breastfeeding women. Willing to get pregnant. 7: Contraindication for taking EGFR-TKIs. 8: Active double cancers. 9: History of severe allergy to drugs. 10: Judgment to attending physician.

Design outcomes

Primary

Measure	Time frame
Disease control rate	—

Secondary

Measure	Time frame
Progression free survival, overall survival, adverse events	—

Countries

Japan

Contacts

Public ContactYusuke inoue

Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

y.inoue@hama-med.ac.jp053-435-2111

Outcome results

None listed

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