A phase III study comparing carboplatin plus pemetrexed followed by maintenance pemetrexed with docetaxel in elderly patients with advanced non-squamous non-small-cell lung cancer (JCOG1210/WJOG7813L CBDCA/PEM vs DOC Phase III)

A phase III study comparing carboplatin plus pemetrexed followed by maintenance pemetrexed with docetaxel in elderly patients with advanced non-squamous non-small-cell lung cancer (JCOG1210/WJOG7813L CBDCA/PEM vs DOC Phase III) - CBDCA/PEM vs DOC Phase III (JCOG1210/WJOG7813L CBDCA/PEM vs DOC Phase III)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011460

Enrollment

430

Registered

2013-08-12

Start date

2013-08-12

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

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

Interventions

A: Docetaxel (60 mg/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) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease 3) 75 years of age or older 4) Performamne status of 0 or 1 5) Regardless of the presence of mesurable lesions 6) Without symptomatic central nervous system metastases 7) No prior chemotherapy or radiotherapy for any other cancers 8) Withour grade 3 or more SVC syndrome, pericardial or pleural effusion 9) No prior surgery accompanied with general anethesia within 28 days before registration 10) No prior palliative radiotherapy for metastatic lesion within 14 days before registration 11)Adequate organ funcion 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous active double malignancies 2) Infectious disease requiring systemic treatment 3) Fever of 38 degrees centigrade or higher 4) Psychotic disorder 5) Receiving systemic treatment of steroid or immunosuppressant 6) Uncontrolled diabetes mellitus treated with insulin 7) Uncontrolled hypertension 8) Unstable angina or myocardial infarction within the past 6 months 9) Positive for HBs antigen 10) Interstitial pneumonitis or lung fibrosis identified by chest CT 11) A past hypersensitive for polysorbate

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Progression-free survival, response rate, symptom score, toxicity	—

Countries

Japan

Contacts

Public ContactIsamu Okamoto

JCOG1210/WJOG7813L Coordinating Office Kyushu University Hospital

JCOG_sir@ml.jcog.jp092-642-5378

Outcome results

None listed

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