Immune Response on Neoadjuvant Therapy in Non-small-cell Lung Cancer (NSCLC)
Multicenter Phase II Study Evaluating Docetaxel, CDDP, and Cetuximab as Induction Regimen Prior to Surgery in Chemo-naive Patients With NSCLC Stage IB, II and IIIA
1 other identifier
interventional
41
1 country
7
Brief Summary
Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2007
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedApril 29, 2014
April 1, 2014
4.4 years
December 1, 2006
April 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall response rate (complete plus partial response) according to RECIST guidelines
June 2011
Secondary Outcomes (6)
Pathological response
June 2011
Metabolic response
June 2011
Immunological response
June 2011
Overall survival
June 2011
Safety profile and tolerability
June 2011
- +1 more secondary outcomes
Interventions
28 days after end of induction chemotherapy
Eligibility Criteria
You may qualify if:
- Histology and staging of the disease
- Histological confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC.
- Anatomically and functionally resectable NSCLC stage IB (T2N0) stage II (T1-2 N1, T3 N0) or stage IIIA (T3 N1) (see TAKO guidelines 2006, www.tako.or.at)
- Measurable disease according to RECIST criteria
- General conditions
- years.
- WHO 0-2; life expectancy of more than 3 months
- Effective contraception for both male and female patients if the risk of conception exists
- Adequate respiratory function, sufficient for necessary surgical treatment
- Adequate hematological function (Hb \> 10 g/dl, ANC \> 2.0 x 10 9/L, platelets \> 100 x 10 9/L).
- Adequate renal and hepatic functions: total bilirubin within normal limits, serum creatinine within normal limits, in case of limit value the creatinine clearance should be \> 60 ml/min, ASAT and ALAT \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL.
- Initial work-up
- Signed initial consent prior to protocol specific procedures.
You may not qualify if:
- Diagnosis
- Evidence of brain metastases or other distant metastasis equivalent to stage IV disease
- History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years
- Other serious concomitant illness or medical condition:
- Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia
- History of significant neurological or psychiatric disorders, including dementia or seizure
- Active infection requiring i.v. antibiotics
- Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy
- Current peripheral neuropathy WHO grade \> 2
- Prior or concurrent therapy
- Prior chemotherapy or immunotherapy for NSCLC
- Prior surgery or radiotherapy for NSCLC
- Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy
- Concurrent continuous treatment with systemic steroids for antiemetic use, intermittent application is allowed
- General conditions
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wolfgang Hilbelead
- Merck Sharp & Dohme LLCcollaborator
- Sanoficollaborator
- TAKO - Tiroler Arbeitskreis Onkologiecollaborator
Study Sites (7)
University Hospital, Internal Medicine
Innsbruck, Tyrol, A-6020, Austria
Hosptial Kufstein
Kufstein, Tyrol, A-6330, Austria
Hospital Natters
Natters, Tyrol, A-6161, Austria
Hospital Zams
Zams, Tyrol, A-6511, Austria
Prim. Dr. Bolitschek
Linz, A-4010, Austria
Prim. Dr. H. Schinko
Linz, A-4020, Austria
OA Dr. Rainer Kolb
Wels, A-4600, Austria
Related Publications (3)
Fossella F, Pereira JR, von Pawel J, Pluzanska A, Gorbounova V, Kaukel E, Mattson KV, Ramlau R, Szczesna A, Fidias P, Millward M, Belani CP. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol. 2003 Aug 15;21(16):3016-24. doi: 10.1200/JCO.2003.12.046. Epub 2003 Jul 1.
PMID: 12837811BACKGROUNDRosell R., et al. Proc Am Soc Clin Oncol 23: 618, 2004
BACKGROUNDBetticher DC, et al. Proc Am Soc Clin Oncol: 1824, 1999
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Hilbe, Prof. Dr.
University Hospital Innsbruck, Internal Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ao. Univ. Prof. Dr.
Study Record Dates
First Submitted
December 1, 2006
First Posted
December 4, 2006
Study Start
January 1, 2007
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
April 29, 2014
Record last verified: 2014-04