A phase II study comparing carboplatin plus pemetrexed followed by maintenance pemetrexed with pemetrexed in elderly patients with advanced epidermal growth factor receptor non-squamous non-small-cell lung cancer (LCEN1301)

A phase II study comparing carboplatin plus pemetrexed followed by maintenance pemetrexed with pemetrexed in elderly patients with advanced epidermal growth factor receptor non-squamous non-small-cell lung cancer (LCEN1301) - A phase II study comparing CBDCA plus PEM followed by maintenance PEM with PEM in elderly patients with advanced EGFR wild type non-sq NSCLC (LCEN1301)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013387

Enrollment

Registered

2014-03-11

Start date

2013-10-18

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

Elderly patients with advanced non-squamous non-small-cell lung cance

Interventions

A: Pemetrexed (500mg/m2) given on day 1 every 3 weeks B: Carboplatin (AUC 5) plus pemetrexed (500 mg/m2) given on day 1 every 3 weeks. If the patients do not develop disease progression, continuation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed advanced non-squamous non-small-cell lung cancer 2) 75 years of age or older 3) Clinical stage IIIB (not amenable to curative radiation) and IV 4) EGFR wild type 5) ECOG performance status of 0 or 2 6) At least one measureable lesion per RECIST 1.0 6) Without symptomatic central nervous system metastases 7) Adequate organ funcion within 2 weeks * Leukocyte count > or = 3000/mm3 * Neutrophil count > or = 2000/mm3 * Platelet count > or = 100000/mm3 * AST and ALT levels < or = 100IU/L * Total bilirubin level < or = 1.5mg/dl * Serum creatinine levels < or = 1.2mg/dl * SpO2 > or = 90% (room air) 8) Estimating Survival more than 2 months 9) Controllable plueral effusion * OK432 pleurodesis for malignant pleural effusion is acceptable. 10) Eligible in case of controlled brain metastases 11) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Pulmonary fibrosis and interstitial pneumonia on chest X-ray or symptomatic pulmonary fibrosis and interstitial pneumonia 2) SVC synd 3) Uncontrolled diabetes, myocardial infarction or cerebral infarction within the past 3 months 4) Infectious disease requiring systemic treatment 5) Psychotic disorder 6) Synchronous or metachronous active double malignancies 7) History of allergic reaction for agents of present treatment 8) Severe heart disease 9) Patients with immunotherapy or vaccine therapy 10) Other ineligible status judged by medical oncologist

Design outcomes

Primary

Measure	Time frame
one-year survival rate	—

Secondary

Measure	Time frame
safety response rate disease control rate progression free survival overall survival QOL	—

Countries

Japan

Contacts

Public ContactTakuma Yokoyama

Kyorin University School of Medicine Department of Respiratory Medicine

taku@ks.kyorin-u.ac.jp0422-47-5511

Outcome results

None listed

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