Chemotherapy Plus Necitumumab in Squamous Non-Small Cell Lung Cancer
Research type
Research Study
Full title
A Single-Arm, Multicenter, Phase 2 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 (NSCLC)
IRAS ID
211243
Contact name
Roma Bansil
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-002041-31
Duration of Study in the UK
2 years, 2 months, 22 days
Research summary
Squamous Non-Small Cell Lung Cancer (NSCLC) accounts for 25% of all lung cancers diagnosed worldwide. However advances in treatment for this type of cancer have remained stagnant in comparison to other types of lung cancer.
Necitumumab, in combination with gemcitabine and cisplatin, is currently approved in the United States and the European Union for the treatment of this cancer type. This combination has shown improvement in patient outcomes with acceptable side effects. However, in certain regions, carboplatin chemotherapy is preferred over cisplatin for some patients due to the different side effects and the convenience of administration.
I4X-MC-JFDA is a Phase 2, single-arm, open-label study that will include approximately 50 patients to evaluate the effectiveness and safety of gemcitabine and carboplatin plus necitumumab in patients with advanced squamous NSCLC who have not received prior chemotherapy for this condition. All patients in this trial will receive one of the current standards of care for this type of cancer (gemcitabine and carboplatin) in combination with necitumumab which may increase the total anti-tumour activity of the treatment. Patients will receive treatment every 3 weeks (for up to 6 treatment cycles) followed by necitumumab alone until their disease gets worse. Study assessments will include: physical examinations, blood tests, ECG and radiological scans (CT, MRI.)
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0388
Date of REC Opinion
22 Sep 2016
REC opinion
Favourable Opinion