Phase I study of combination chemotherapy with erlotinib and S-1 as the 2nd or 3rd-line treatment in platinum-refractory advanced non-small cell lung cancer (TORG0808)

Phase I study of combination chemotherapy with erlotinib and S-1 as the 2nd or 3rd-line treatment in platinum-refractory advanced non-small cell lung cancer (TORG0808) - Phase I study of combination chemotherapy with erlotinib and S-1 in pretreated non-small cell lung cancer(TORG0808)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003421

Enrollment

Registered

2010-03-31

Start date

2008-12-01

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 administers 150mg/body orally once a day. Patients receive oral doses of S-1 twice daily after meals from days 1 to 14 of each 21-day cycle at the following dose level. Level 0:60mg/m2day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histology/cytology-proven non-small cell lung cancer 2)Stage IIIB (wide radiation field, malignant pleural effusion or contralateral supraclavicular lymph node) or Stage IV 3)Previous 1- or 2-regimen chemotherapy consisting of platinum 4) No prior chemotherapy with EGFR-TKI or fluoropyrimidine 5)Presence of measurable disease 6)more than 4weeks after the last treatment 7)measurable disease per RECIST criteria 8)ECOG PS of 0-1 9)Age of 20 years or over 10)Adequate reserves for marrow, renal, hepatic, and pulmonary functions 11)Acquisition of written informed consent

Exclusion criteria

Exclusion criteria: 1) no other evaluable lesion after the prior irradiation for the primary tumor 2) the superior vena caval syndrome 3) previous drug allergy 4,5) massive pericardial, pleural effusion, or ascites 6,9,14) serious underlying diseases (interstitial pneumonia, serious cardiac diseases, serious infection) 7,8)diarrhea to last, ileus, or intestinal tract paralysis 10) previous radiotherapy for cest or ilium bone 11) symptomatic brain metastasis 12) concomitant malignancy 13) uncontrolled diabetes mellitus 15)mental disorder to become the clinical problem 16)hoped to be pregnant/ nursing 17)those judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Maximum Tolerated Dose of Erlotinib/S-1 combination therapy	—

Secondary

Measure	Time frame
Anti tumor efficacy	—

Countries

Japan

Contacts

Public ContactNaoyuki Nogami

National hospital organization shikoku cancer center Administration office

Nnogami@shikoku-cc.go.jp089-999-1111

Outcome results

None listed

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