Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT00115518 | Completed Phase 2

• 1 other identifier: NEAR L-284/2004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function)

  3 yrs

Secondary Outcomes (3)

• response (RECIST criteria of primary tumor and enlarged lymphnodes)

  3 yrs

• survival (at 3 years)

  3 yrs

• time to progression (locally and systemically)

  3 yrs

Interventions

cetuximab DRUG

After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (2)

• Jensen 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 RESULT

• Jensen 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 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Klaus K Herfarth, MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2005
• First Posted: June 23, 2005
• Study Start: May 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2010
• Last Updated: August 5, 2011

Record last verified: 2011-02

Locations

DE (1)