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 vinorelbine

• Conditions: MedDRA version: 8.1Level: LLTClassification code 10061873; Stage 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 vinorelbine

• Registration Number: EUCTR2006-000899-32-DE
• Lead Sponsor: EMD Pharmaceuticals, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. 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, gemcitabine or vinorelbine. 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
8. ECOG performance status 0-1
9. Life expectancy >12 weeks
10. Adequate baseline organ functions, defined as follows:
Serum creatinine =1.5 × upper limit of normal (ULN)
In case of borderline values for serum creatinine, creatinine clearance must be =45 mL/min
Total bilirubin <1.5 × ULN
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =2.5 × ULN (Subjects with liver metastases should have ALT/AST <5 × ULN.)
Absolute neutrophil count =1500/mm3
Platelet count =100,000/mm3
Hemoglobin level =10 g/dL
11. If procreative potential (male or female), willingness to use effective contraceptive methods for the duration of treatment and continuing for 2 months after the last dose. Subjects of procreative potential are defined as any fertile male, or any female who has experienced menarche and who is not postmenopausal (defined as age-related amenorrhea =12 months) or who has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
10. Concurrent malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in
situ carcinoma of the cervix
11. Any significant disease that, in the Investigator’s opinion, should exclude the subject from the study
12. History of significant neurologic or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
13. History of drug abuse within 6 months prior to the start of study treatment
14. Known conditions that require concurrent treatment with a nonpermitted drug (see Section 6.8.2 of the protocol)
15. Presence of a contraindication to the study treatment(s) according to the current Investigator’s Brochure (IB) for matuzumab and the labeling for pemetrexed
16. Known hypersensitivity to the study treatment or any of its components
17. Participation in another clinical study within 30 days prior to the start of study treatment
18. Legal incapacity or limited legal capacity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified