A phase II study of erlotinib/S-1 combination therapy in patients with recurrent or advanced non-small lung cancer who do not possess active EGFR mutation.(TORG0913)

A phase II study of erlotinib/S-1 combination therapy in patients with recurrent or advanced non-small lung cancer who do not possess active EGFR mutation.(TORG0913) - A phase II study of erlotinib/S-1 combination therapy in patients with recurrent or advanced non-small lung cancer who do not possess active EGFR mutation.(TORG0913)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003422

Enrollment

Registered

2010-03-31

Start date

2010-03-01

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

Erlotinib is administered 150mg/body day orally every day. S-1 is administered 40 mg/m2 twice daily(after breakfast and dinner), days 1-14 every 21 days orally.

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)patients who do not possess active EGFR mutation 5)No prior chemotherapy with EGFR-TKI or fluoropyrimidine 6)possible cases with oral administration 7)Performance status (ECOG)0-2 8)Presence of measurable disease per RECIST criteria 9)close and meticulous observation with (or without hospitalization) during the first 2-4 weeks of treatment 10)Age of 20 years or over 11)Adequate reserves for marrow, renal, hepatic, and pulmonary functions t 12)more than 4 weeks after the last chemotherapy 13)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)massive pericardial effusion, or ascites 5,8,16)serious underlying diseases(interstitial pneumonia, serious cardiac diseases, serious infection) 6,7)diarrhea to last, ileus, or intestinal tract paralysis 9)symptomatic ophthalmologic disease 10)current or previous (within the last 1 year)history of GI perforation 11)serious non-healing ulcer 12)symptomatic or steroid-requiring brain metastases 13,14)active concomitant malignancy 15)uncontrolled diabetes mellitus 17)severe psychological disease 18)hoped to be pregnant/nursing 19)those judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Disease control rate(DCR), Progression free survival(PFS), Overall survival(OS), safety	—

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