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Clinical Trials/EUCTR2006-000899-32-AT
EUCTR2006-000899-32-AT
Active, not recruiting
Not Applicable

Randomized, phase II, open-label controlled study of two different doses and schedules of EMD 72000 (matuzumab) in combination with pemetrexed, or pemetrexed alone, as second-line treatment in subjects with Stage IIIB/IV non-smallcell lung cancer and progressive disease on or after first-line treatment with a platinum analogue in combination with either taxanes or gemcitabine

EMD Pharmaceuticals, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany0 sites150 target enrollmentMay 11, 2006
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
EMD Pharmaceuticals, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany
Enrollment
150
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 11, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
EMD Pharmaceuticals, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany

Eligibility Criteria

Inclusion Criteria

  • •1\. First written informed consent provided prior to any prescreening procedure and second written informed consent provided prior to any screening procedure
  • •2\. Male or female, \=18years of age
  • •3\. Histologically or cytologically confirmed diagnosis of NSCLC
  • •4\. Demonstrated progressive disease on or after first\-line chemotherapy for Stage IIIB/IV disease. The first\-line therapy must consist of platinum\-based regimens in
  • •combination with taxanes or gemcitabine. Stage IIIB patients must have measurable disease (tumor) without clinically significant pleural effusion unless the pleural
  • •can be effectively drained prior to admission into the study.
  • •5\. A chemotherapy\-free interval of at least 3 weeks between the end of first\-line chemotherapy and start of study treatment
  • •6\. At least 1 measurable lesion according to the modified WHO criteria as defined in Section 7\.2\.2
  • •7\. Archived tissue or cytologic sample available for the determination of EGFR expression, and evidence of tumor EGFR (HER\-1\) expression in the most recent
  • •available sample

Exclusion Criteria

  • •1\. Radiotherapy or major surgery within 30 days prior to the start of study treatment
  • •2\. Prior treatment with an EGFR\-directed therapy or with EGFR signal transduction inhibitors
  • •3\. Prior treatment with pemetrexed
  • •4\. Pregnant (confirmed by ß\-HCG) or lactating female
  • •5\. Weight loss \>10% within 12 weeks prior to the start of study treatment
  • •6\. Documented or symptomatic brain metastases or leptomeningeal disease
  • •7\. Myocardial infarction within 6 months prior to the start of study treatment, uncontrolled congestive heart failure, or any current New York Heart Association
  • •Grade III or IV cardiovascular disorder despite treatment
  • •8\. Presence of a \=Grade 2 preexisting skin disorder (except for alopecia)
  • •9\. Previous diagnosis of autoimmune disease with significant organ involvement

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Randomized, phase II, open-label controlled study of two different doses and schedules of EMD 72000 (matuzumab) in combination with pemetrexed, or pemetrexed alone, as second-line treatment in subjects with Stage IIIB/IV non-smallcell lung cancer and progressive disease on or after first-line treatment with a platinum analogue in combination with either taxanes, gemcitabine or vinorelbineStage IIIB/IV non-small cell lung cancer and progressive disease on or afterfirst-line treatment with a platinum analogue in combination with either taxanes, gemcitabine or vinorelbineMedDRA version: 8.1Level: LLTClassification code 10061873
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