Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer

Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer - Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010090

Enrollment

Registered

2013-02-21

Start date

2013-03-01

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

ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer

Interventions

Erlotinib and Crizotinib combinationtherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Non-small cell lung cancer proven by histology and/or cytology and ALK positive lung cancer by IHC or FISH or RT-PCR. 2))Patients who have previously treated with ALK inhibiter more than 3 weeks and 3) With one or more measurable disease based on RECIST (ver.1.1) 4) Performance Status (ECOG) : 0-1 5) 20<= years 6) Patients providing written informed consent 7) Adequate function of vital organs, including normal hematopoietic liver and renal function as following: WBC >= 3,000/mm3 or Neutrophils >= 1,500/mm3 Hemoglobin >= 9.0 g/dL Platelets >= 100,000/mm3 AST and ALT, x 2.5 of upper limit of normal (ULN) or less. Total bilirubin <= 1.5mg/mL Serum creatinine <= 1.5mg/dL Creatinin crealance>=30mL/min PT-INR <1.5 Urinary protein <2+ PaO2>=60torr or SpO2>=95% 8)interval: (1) chemotherapy, more than 3 weeks after the last chemotherapy. (2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs. (3) Operation, more than 4 weeks after the last operation (including pleurodesis) 9) A life expectancy of more than 3 months

Exclusion criteria

Exclusion criteria: 1)No prior treatment with EGFR-TKI 2)Patients with uncontrollable complications(e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea). 3)Patients with active severe brain metastasis. 4)1)Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 5)History of active double cancer within 5 years prior to the study. 6)Patients with symptomatic brain metastasis 7)Impossible cases with oral administration. 8)Pregnancy or lactation 9) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame
safety	—

Secondary

Measure	Time frame
Response rate, disease control rate, progression free survival, overall Survival,	—

Countries

Japan

Contacts

Public ContactKeita Kudo

Cancer institute hospital, Japanese Foundation For Cancer Reseach Medical thoracic oncology

keita.kudo@jfcr.or.jp03-3520-0111

Outcome results

None listed

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