Clinical trial · Interventional
Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer
Randomized Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Patients With Advanced Non-small Cell Lung Cancer: Dual-agent Molecular Targeting of EGFR (DATE)
NCT01498562CI-TRIAL-00016174DATEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
| Gefitinib and Nimotuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gefitinib plus Nimotuzumab
- description
- Combination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly)
- interventionNames
- Drug: Gefitinib and Nimotuzumab
- type
- ACTIVE_COMPARATOR
- label
- Gefitinib alone
- description
- Mono-therapy group: Gefitinib(250mg daily)
- interventionNames
- Drug: Gefitinib
Primary outcomes (1)
- measure
- Progression free survival rate at 3 months
- timeFrame
- 3 months after randomization of last patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of written informed consent prior to any study specific procedures * Unresectable non-small cell lung cancer * ECOG performance status of 0 to 2 * Male or female; ≥ 20 years of age * Subjects whose disease has progressed after platinum-based chemotherapy * Subjects with measurable lesion Exclusion Criteria: * Inadequate organ functions * Disease progression after 2 or more previous chemotherapy regimens * Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab * Any clinically significant gastrointestinal abnormalities * Past medical history of interstitial lung disease * Pregnant or lactating female
References
Publications (1)
- DERIVEDKim HR, Jang JS, Sun JM, Ahn MJ, Kim DW, Jung I, Lee KH, Kim JH, Lee DH, Kim SW, Cho BC. A randomized, phase II study of gefitinib alone versus nimotuzumab plus gefitinib after platinum-based chemotherapy in advanced non-small cell lung cancer (KCSG LU12-01). Oncotarget. 2017 Feb 28;8(9):15943-15951. doi: 10.18632/oncotarget.13056. PMID 27823977