Randomized phase II trial evaluating epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) plus chemotherapy in non-small cell lung cancer (NSCLC) patients with previously treated EGFR-TKI.

Randomized phase II trial evaluating epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) plus chemotherapy in non-small cell lung cancer (NSCLC) patients with previously treated EGFR-TKI. - LOGIK 1102: Standard chemotherapy versus EGFR-TKI plus chemotherapy beyond progression (CVEC) study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006976

Enrollment

Registered

2011-12-28

Start date

2011-11-01

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

NSCLC with previously treated EGFR-TKI.

Interventions

A:Reference arm Single-agent chemotherapy B:Experimental arm Single-agent chemotherapy plus EGFR-TKI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically or cytplogically confirmed non-small cell lung cancer. 2. Patients with clinical stage IIIB, IV or postoperative recurrence, and unsuitable for radiotherapy. Patients have previously treated with platinum-based chemotherapy as a 1st-line. *Adjuvant and neo-adjuvant chemotherapy are not considered as one regimen of chemotherapy before 12 months. *Pleurodesis with OK432 or bleomycin are not considered as one regimen of chemotherapy. 3. Patients have previously treated with EGFR-TKI as a 2nd-line or more chemotherapy, and have a disease control at least 8weeks. 4. Within 42 days after disease progression. 5. Patients have treated radiotherapy who have uncontrollable brain metastases. 6. Patients with evaluable disease (not necessarily to be measurable) 7. Age eligible for study: 20 years and above 8. ECOG PS 0-2 9. Sufficient organ function WBC >=2000/mm3, Hb >=9.0 g/dL Plt >=100000/mm3 Bil =<1.5mg/dL GOT/GPT <=100IU/L Cr. =<1.2mg/dL SpO2>=92% 10. Patients are expected to live over 12 weeks. 11. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients could not received EGFR-TKI (gefitinib 250mg or erlotinib 150mg) more than evry 3 days. 2. History of symptomatic brain metastases. 3. History of obvious and widely distributed interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. 4. History of radiation therapy for mediastinum or lung within 28 days at the time of entry. (Radiation therapy for other parts is not adapted for this exclusion cliteria.) 5. History of poorly controlled pleural effusion, pericardial. effusion or ascites necessitating drainage. 6. History of major surgery within 28 days. 7. History of active infection. 8. History of active double cancer 9. History of severe drug allergy 10. History of pregnancy or lactation 11. Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Disease control rate at 6,8,12weeks Overall survival Adverse Event	—

Countries

Japan

Contacts

Public ContactFumihiko Hirai, Takashi Seto

National Kyushu Cancer Center Department of Thoracic Oncology

hirai.f@nk-cc.go.jp092-541-3231

Outcome results

None listed

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