The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients

The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients - The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007307

Enrollment

Registered

2012-02-16

Start date

2012-02-01

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

erlotinib 150mg/day prednisolone 10mg/ day 4weeks erlotinib 150mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytological confirmed non-small cell lung cancer 2. Age: 20years old or older 3. ECOG PS: 0-2 4. Adequate organ function 5. Life expectancy more than 3 months 6. Written informed consent from the patient

Exclusion criteria

Exclusion criteria: 1. History of severe drug allergy 2.Prior treatment with drugs (Gefitinib or Cetuximab)which act on an EGFR system. 3.The patient by whom revelation of a critical adverse event is expected with a prednisolone tablet 4. Pregnant or breast-feeding females 5.Patient of the past of an active interstitial lung obstacle or a merger 6. Uncontrollable infectious disease 7. Uncontrollable peptic ulcer 8. Glaucomatous patient 9. Patient of serious illness skin disease 10. The patient who has critical complications. (Uncontrollable cardiac disease, liver cirrhosis, continuous watery diarrhea) 11. The patient in whom oral ingestion is impossible. 12. Decision of ineligibility by a physician

Design outcomes

Primary

Measure	Time frame
A two or more-Grade skin adverse event rate	—

Secondary

Measure	Time frame
Adverse events Skin adverse event rate and revelation time A two or more-Grade skin adverse event revelation time Erlotinib administration rate QOL(EuroQol Group EQ-5D-3L)	—

Countries

Japan

Contacts

Public ContactShinya Sagisaka

Iwata City Hospital Respiratory Medicine

sagisakas@hospital.iwata.shizuoka.jp0538-38-5000

Outcome results

None listed

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