Phase I/II study of Irinotecan and Erlotinib in patients for EGFR mutation negative previously treated non-small-cell lung cancer.

Phase I/II study of Irinotecan and Erlotinib in patients for EGFR mutation negative previously treated non-small-cell lung cancer. - Phase I/II study of Irinotecan and Erlotinib in patients for EGFR mutation negative previously treated non-small-cell lung cancer.(OULCSG-1101)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005181

Enrollment

Registered

2011-03-03

Start date

2011-03-01

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

Irinotecan and Erlotinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Stage IIIB/IV non-small cell lung cancer proven by histology and/or cytology. (2)previously chemotherapy treated. (3)Possible cases with oral administration. (4)No prior treatment with TKI or Mab which affect to HER family. (5)No prior treatment with irinotecan. (6)Diagnosed no mutation or heterozygosity of UGT1A1*6/*28 (7)Those without any active EGFR mutations in the tumor specimens. (8)Measurable lesion by RECIST. (9)ECOG Performance status(PS) of 0-1. (10)A life expectancy of more than 3 months. (11)No severe impairment of major organs (bone marrow, heart, lungs, liver, kidneys, etc.), laboratory data within 14 days WBC >=3,000/mm3 and <=12,000mm3 neutrophil >=1,500/mm3 platelet >=100,000/mm3 hemoglobin >=8.0g/dL AST and ALT <=2.5 ULN T-Bil <=1.5 ULN Cr <=UNL SpO2(Room air)>=92% (12)Interval from previous treatment, of following, at enrollment; 1)Equal or more than 4 weeks after completion of previous chemotherapy 2)Equal or more than 12 weeks after completion of thoracic irradiation. / Equal or more than 2 week after completion of irradiation except for thoracic irradiation 3)Equal or more than 4 weeks after surgical intervention. (13)Written informed consent.

Exclusion criteria

Exclusion criteria: (1)Diagnosed mutation or heterozygosity of UGT1A1*6/*28. (2)Serious drug allergy. (3)Interstitial pneumonia documented obviously in chest X ray. (4)massive pleural or pericardial effusion ,or ascites. (5)active severe infections. (6)Active synchronous malignancies. (7)Pregnant or beeast-feeding woman or patient who doesn't agree to contraception. (8)Serious psychological disease. (9)brain metastasis. (10)Clinically significant heart disease (myocardial infarction within 12 months, etc.). (11)Uncontrolled diabetes mellitus. (12)Watery diarrhea. (13)Ileus or bowel obstruction. (14)bleeding that requires medication or transfusion. (15)Clinically significant complication. (16)Investigator's judgement.

Design outcomes

Primary

Measure	Time frame
PhaseI:determine the recommend dose of irinotecan and erlotinib therapy PhaseII:response rate	—

Secondary

Measure	Time frame
Phase I (1)safety (2)pharmacokinetics (3)response rate PhaseII (1)safety (2)disease control rate (3)overall survival(OS) (4)progression-free survival(PFS)	—

Countries

Japan

Contacts

Public ContactTakashi Kijima

Osaka Univ.Hospital Respiratory Medicine

tkijima@imed3.med.osaka-u.ac.jp06-6879-3833

Outcome results

None listed

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