Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior

Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior - Randomized phase II study of Erlotinib vs. S-1 for non-small lung cancer after failure of two or three prior

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005308

Enrollment

Registered

2011-03-25

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

S-1 Erlotinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)In 20-74 years of age at the time of consent. 2)Histologically or cytrologically confirmed diagnosis of non-small cell lung cancer. 3)Prior chemotherapy with more than two regimens, including at least one platinum-based (CDDP or CBDCA) combination. Use of molecular-targeting drugs and adjuvant therapy are not countable to the prior regimens. Prior concurrent therapies including endocrine therapy, surgery, and radiotherapy are acceptable for the inclusion. 4)Patients who have measurable lesion. 5)Eastern Cooperative Oncology Group(ECOG)Performance status 0-2. 6)Sufficient function of main organ( bone marrow,lung,liver,renal,heart)filled the following criteria. White blood cell count>=3000/mm3 Absolute granulocyte count >= 1500/mm3 Hemoglobin >= 9.0g/dL Platelet count >= 100,000/mm3 Serum bilirubin <= 1.5 mg/dL AST,ALT <100 IU/l Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min PaO2(Room air) >=60Torr (or SpO2>=95%) 7)Life expectancy more than 3 months. 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Previous histories of drug allergy, which may increase the risk of this study. 2)Serious concomitant infection. 3)Usages of oral steroids or immunosuppressive drugs. 4)Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes. 5)Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 6)Patients with EGFR mutation or having past history of administration of EGFR tyrosine kinase inhibitors. 7)Severe pleural, abdominal or cardiac effusion. 8) Patients with symptomatic brain metastasis 9)Patients with active concomitant malignancy 10)Pregnant, lactating women. 11)Inappropriate patients judged by physicians

Design outcomes

Primary

Measure	Time frame
Disease control rate	—

Secondary

Measure	Time frame
Overall survival Progression free survival Response rate Safty	—

Countries

Japan

Contacts

Public ContactHajime Asahina

Hokkaido University Department of Respiratory Medicine

hajime.asahina@gmail.com011-706-5752

Outcome results

None listed

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