Study of Gemcitabine-Carboplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
- Conditions
- ocally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002041-31-IT
- Lead Sponsor
- ELI LILLY & COMPANY, LILLY CORPORATE CENTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
- 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) yes
F.1.3.1 Number of subjects for this age range 6
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>•to evaluate OS, PFS, and DCR;<br>•to evaluate the safety profile of necitumumab in combination with gemcitabine-carboplatin chemotherapy;<br>•to characterize the PK of necitumumab.<br><br>;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 Outcome Measures
Name Time Method Secondary end point(s): Secondary efficacy endpoints will include:<br>. OS<br>. PFS<br>. DCR (CR, PR, and SD) based on tumor assessment using RECIST 1.1<br>The safety endpoints evaluated will include but are not limited to the<br>following:<br>. TEAEs, AEs, SAEs, and hospitalizations<br>. Clinical laboratory tests, ECGs, vital signs, and physical examinations<br>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<br>have completed at least 2 cycles (or otherwise discontinued study treatment).