Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)

Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104) - Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000027

Enrollment

284

Registered

2005-07-22

Start date

2002-01-01

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

Interventions

Docetaxel alone Docetaxel and Gemcitabine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically and/or cytologically proven NSCLC 2) Advanced Stage (IV or IIIB) 3) One prior platinum-based chemotherapy 4) Excluded either docetaxel or gemcitabine 5) Age: 20 to 75 6) PS (ECOG scale): 0, 1 7) Adequate organ function 8) WBC>=4,000 /mm3, ANC>=2,000 /mm3, Hb>=9.5 g/dL, PLT>=100,000 /mm3 9) AST/ALT =70 mmHg (Room air) 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Symptomatic brain metastasis 2) Double cancer 3) Superior vena cava syndrom 4) Massive pleural effusion or ascitis 5) Spiral compression 6) Severe hypertension 7) Diabetis melitus treated with insulin 8) Concommitant infectious disease excluded hepatic fever 9) Interstitial lung disease 10) Hypersinsitivity to Polysorbate 80 11) Need to treatment with steroid, ketoconazole, nifedipine or erithromycin 12) Psycologic illness 13) Women during pregbnancy or lacteted

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Adverse events Progression-free survival	—

Countries

Japan

Contacts

Public ContactKoji Takeda, MD

JCOG0104 Coordinating Office Department of Plumonay Medicine, Osaka City General Hospital

JCOG_sir@ml.jcog.jp

Outcome results

None listed

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