Clinical trial · Interventional
Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
NCT00112346CI-TRIAL-00019623completedPhase 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)
The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.
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 Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab + platinum + gemcitabine | Drug | — | UNRESOLVED |
| Platinum + Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- interventionNames
- Drug: Cetuximab + platinum + gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: Platinum + Gemcitabine
Primary outcomes (1)
- measure
- tumor response per treatment arm
Secondary outcomes (1)
- measure
- disease control, symptom response, symptomatic progression, & progression free survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy. * Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva). * Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease. * Must be able to carry out work of light or sedentary nature (e.g. light house work, office work). * It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest. Exclusion Criteria: * Women who are pregnant or breastfeeding. * Women with a positive pregnancy test on enrollment or prior to study drug administration. * Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial). * Symptomatic or uncontrolled metastases in the central nervous system (CNS). * Peripheral neuropathy. * Inadequate hematologic function defined by an absolute neutrophil count (ANC) \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or a hemoglobin level \< 9g/dL. * Inadequate liver function. * Inadequate kidney function.
References
Publications (0)
Data not yet available
No reference posted for this study.