Phase 2
N=150
Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer
Lung Cancer · Non Small Cell Lung Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00111839 ↗Enrolled (actual)
150
Serious AEs
16.9%
Results posted
Apr 2018
Primary outcome: Primary: Number of Participants With Objective Response Assessed by Independent Review Committee — 2; 8; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pemetrexed (Drug); Matuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EMD Serono
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response Assessed by Independent Review Committee |
2; 8; 1 | — |
| SECONDARY Overall Survival (OS) |
7.9; 12.4; 5.9 | — |
| SECONDARY Progression-Free Survival (PFS) |
2.7; 2.3; 2.5 | — |
| SECONDARY Duration of Objective Response Assessed by Independent Review Committee |
NA; NA; NA | — |
| SECONDARY Change From Baseline to Cycle 2 in Global Quality of Life (QoL), as Assessed Using Lung Cancer Symptom Scale (LCSS) |
35.9; 31.1; 35.8; 3.5; 0.8; 15.7 | — |
Summary
This open-label, multicenter, randomized, controlled, Phase II study is planned to answer questions about how the drug, matuzumab (EMD 72000), works and is part of an effort aimed to develop better treatment for advanced lung cancer by combining matuzumab, a monoclonal antibody, with a chemotherapy treatment, called pemetrexed.
Eligibility Criteria
Inclusion Criteria
- Written informed consent provided prior to any screening procedure
- Male or female, greater than (>) 18 years of age
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Demonstrated PD 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/IV participants must have measurable disease (tumor) without clinically significant pleural effusion unless the pleural effusion can be effectively drained prior to admission into the study
- A chemotherapy-free interval of at least 3 weeks between the end of first-line chemotherapy and start of study treatment
- At least 1 measurable lesion according to the modified World Health Organization (WHO) criteria
- Archived tissue or cytologic sample available for the determination of epidermal growth factor receptor (EGFR) expression
- Eastern cooperative oncology group (ECOG) performance status 0-1
- Life expectancy >12 weeks
- Adequate baseline organ functions, defined as: Serum creatinine less than or equal to (≤)1.5*upper limit of normal (ULN). In case of borderline values for serum creatinine, creatinine clearance must be greater than or equal to (≥) 45 millimeters per minute (mL/min); Total bilirubin 10% within 12 weeks prior to the start of study treatment
- Documented or symptomatic brain metastases or leptomeningeal disease
- 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
- Presence of a Grade ≥2 preexisting skin disorder (except for alopecia)
- Previous diagnosis of autoimmune disease with significant organ involvement
- 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
- Any significant disease that, in the Investigator's opinion, should exclude the participant from the study
- History of significant neurologic or psychiatric disorder (for example, dementia, seizures, or bipolar disorder)
- History of drug abuse within 6 months prior to the start of study treatment
- Known conditions that require concurrent treatment with a nonpermitted drug
- Presence of a contraindication to the study treatment(s) according to the current Investigator's Brochure (IB) for matuzumab and the labeling for pemetrexed
- Known hypersensitivity to the study treatment or any of its components
- Participation in another clinical study within 30 days prior to the start of study treatment
Data sourced from ClinicalTrials.gov (NCT00111839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.