A Single-Arm, Multicenter, Open-Label, Phase 2 Study of;Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab;(IMC-11F8) in the First-Line Treatment of Patients With;Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- advance squamous cell NSCLC / specific type of lungcancer1003866610029107
- Registration Number
- NL-OMON40000
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
Histologically or cytologically confirmed squamous NSCLC;
Stage IV disease at time of study entry based on AJCC 7th edition;
Measurable disease at time of study entry as defined by RECIST 1.1;
The patient has an Eastern Cooperative Oncology Group performance status score of 0-1, the patient has an estimated life expectancy of at least 12 weeks and in the judgment of the investigator, will be able to complete at least 2 cycles of treatment.
Nonsquamous NSCLC;
Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor;
Previous chemotherapy for NSCLC;
Major surgery or received any investigational therapy in the 4 weeks prior to study enrollment;
Chest irradiation within 12 weeks prior to study enrollment (except palliative irradiation of bone lesions,
which is allowed);
Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (Patients who have completed radiotherapy for brain metastases at least 4 weeks prior to receiving treatment, who are now nonsymptomatic and have not required treatment with steroids or anticonvulsants during the 2 weeks prior to receiving treatment, are eligible.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to estimate ORR. The denominator of ORR<br /><br>should count each patient enrolled who receives any amount of study drug<br /><br>(necitumumab, gemcitabine, and/or cisplatin), who has a complete radiographic<br /><br>assessment at baseline, and who has at least 1 complete radiographic assessment<br /><br>postbaseline. Among patients counted in the denominator, the numerator counts<br /><br>those with a best tumor response of PR or CR.<br /><br><br /><br>Efficacy: For these definitions, the date of study enrollment is the date of<br /><br>first dose of study drug (necitumumab, gemcitabine, and/or cisplatin).<br /><br>* Tumor response will be assessed according to RECIST 1.1 every 6 weeks (±3<br /><br>days) by the investigator with confirmatory assessment for patients with an<br /><br>objective assessment of PR or CR obtained at the next routine scheduled imaging<br /><br>time point (that is, after 6 weeks ±3 days).</p><br>
- Secondary Outcome Measures
Name Time Method