Clinical trial · Interventional
Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity
- 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)
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cetuximab/Radiation
- description
- Cetuximab (C225) and Radiation
- interventionNames
- Biological: cetuximab
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- 11-month Survival Rate
- timeFrame
- From baseline to 11 months.
- description
- Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with "success", unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIA or IIIB disease * Must be a candidate for curative radiotherapy * Not a candidate for other concurrent chemotherapy and radiotherapy * No surgical treatment available * No pleural effusion suspected or proven to be malignant * No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days PATIENT CHARACTERISTICS: Age \* 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years) * ECOG 2 (age 18 to 64 years) Life expectancy \* At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * AST ≤ 3 times ULN Renal * Creatinine ≤ 1.5 times ULN Pulmonary * FEV\_1 ≥ 1 L * No idiopathic pulmonary fibrosis Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Magnesium normal * No uncontrolled infection * No other severe underlying disease that would preclude study entry * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma * No major psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy \* Not specified Chemotherapy * See Disease Characteristics * No prior chemotherapy for NSCLC Endocrine therapy \* Not specified Radiotherapy * No prior therapeutic radiotherapy to the chest * No concurrent intensity modulated radiotherapy Other \* No prior epidermal growth factor receptor inhibitors
References
Publications (1)
- RESULTJatoi A, Schild SE, Foster N, Henning GT, Dornfeld KJ, Flynn PJ, Fitch TR, Dakhil SR, Rowland KM, Stella PJ, Soori GS, Adjei AA. A phase II study of cetuximab and radiation in elderly and/or poor performance status patients with locally advanced non-small-cell lung cancer (N0422). Ann Oncol. 2010 Oct;21(10):2040-2044. doi: 10.1093/annonc/mdq075. Epub 2010 Jun 21. PMID 20570832