Clinical trial · Interventional
Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III
NCT00115518CI-TRIAL-00005324completedPhase 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 purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial). Endpoints: safety and feasibility (primary) response, survival, time to progression (secondary)
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function)
- timeFrame
- 3 yrs
Secondary outcomes (3)
- measure
- response (RECIST criteria of primary tumor and enlarged lymphnodes)
- timeFrame
- 3 yrs
- measure
- survival (at 3 years)
- timeFrame
- 3 yrs
- measure
- time to progression (locally and systemically)
- timeFrame
- 3 yrs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified NSCLC * Not eligible for Radiochemotherapy or patient refuses chemotherapy * FeV1 \>1.5 L or min. 50% * KPI \>= 70% * Life expectancy \> 6 months * Weight loss less than 10% of body weight in 12 months * Compliance * Adequate blood counts (LC \> 3000 x 10\^3/ml, Tc \>100000 x 10\^3/ml, Hb \> 10 g/dl) * Effective contraception Amendment 1/07: FeV1 \>1.2 L or min 40% Exclusion Criteria: * Active infection * Reduced liver function * Vena cava superior syndrome * Malignant pleural effusion * Pregnancy or breast feeding * Additional serious systemic disease * Secondary malignancy (except carcinoma in situ of the cervix, basalioma of the skin, secondary cancer in remission for \> 5 years) * Known allergies against proteins * History of former antibody therapy * Allergy against i.v. contrast agents
References
Publications (2)
- RESULTJensen AD, Munter MW, Bischoff HG, Haselmann R, Haberkorn U, Huber PE, Thomas M, Debus J, Herfarth KK. Combined treatment of nonsmall cell lung cancer NSCLC stage III with intensity-modulated RT radiotherapy and cetuximab: the NEAR trial. Cancer. 2011 Jul 1;117(13):2986-94. doi: 10.1002/cncr.25888. Epub 2011 Jan 24. PMID 21264838
- DERIVEDJensen AD, Munter MW, Bischoff H, Haselmann R, Timke C, Krempien R, Sterzing F, Nill S, Heeger S, Hoess A, Haberkorn U, Huber PE, Steins M, Thomas M, Debus J, Herfarth KK. Treatment of non-small cell lung cancer with intensity-modulated radiation therapy in combination with cetuximab: the NEAR protocol (NCT00115518). BMC Cancer. 2006 May 8;6:122. doi: 10.1186/1471-2407-6-122. PMID 16681848