Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 19.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Portrazza
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Necitumumab
CAS Number: 906805-06-9
Other descriptive name: NECITUMUMAB
Concentration unit: mg/ml
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have confirmed diagnosis of locally advanced or metastatic NSCLC predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report. - Has an EGFR protein expressing tumor (defined by local IHC test). - Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Has tumor tissue available for biomarker analyses. - Has resolution of all clinically significant toxic effects of prior adjuvant and/or neoadjuvant chemotherapy, surgery, radiotherapy (with the exception of alopecia) to Grade =1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. - Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1 - Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy (Biologic agents (for example, antibodies) and Immunotherapy >=4 weeks; Chest radiotherapy >= weeks; Major surgery, excluding biopsy >=4 weeks) 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 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: - Has nonsquamous NSCLC - Has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor - Has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (patients who have received adjuvant and/or neoadjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy). - Has undergone major surgery or received any investigational therapy in the 4 weeks prior to study enrollment. - Has undergone chest irradiation within 4 weeks prior to study enrollment (except palliative irradiation of bone lesions, which is allowed). - Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. - Has a bleeding tumor - History of arterial or venous thromboembolism within 3 months prior to study enrollment. - Has a history or evidence of current clinically-relevant coronary artery disease of current = Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current = Class III as defined by the New York Heart Association. - Has experienced myocardial infarction within 6 months prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the ORR (CR + PR) associated with gemcitabine-carboplatin plus necitumumab in patients with locally advanced or metastatic EGFR expressing squamous NSCLC who have not received prior chemotherapy for this condition.;Secondary Objective: The secondary objectives of this study are: • to evaluate OS, PFS, and DCR; • to evaluate the safety profile of necitumumab in combination with gemcitabine-carboplatin chemotherapy; • to characterize the PK of necitumumab. ;Primary end point(s): ORR (CR + PR) based on tumor assessment using RECIST 1.1;Timepoint(s) of evaluation of this end point: Approximately 6 months after enrolment completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints will include: . OS . PFS . DCR (CR, PR, and SD) based on tumor assessment using RECIST 1.1 The safety endpoints evaluated will include but are not limited to the following: . TEAEs, AEs, SAEs, and hospitalizations . Clinical laboratory tests, ECGs, vital signs, and physical examinations Assess PK parameters for necitumumab;Timepoint(s) of evaluation of this end point: Safety: An interim safety analysis will be performed when at least 15 pts have completed at least 2 cycles (or otherwise discontinued study treatment). All endpoints: approximately 12 months after enrolment completion. | — |
Countries
Belgium, Russian Federation, Turkey
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed