Phase 3 open label study with nab-Paclitaxel in patients with NSCLC

• Research type

  Research Study

• Full title

  A Phase III, randomized, open-label, multi-center, safety and efficacy study to evaluate nab®-paclitaxel (Abraxane) as maintenance treatment after induction with nab-paclitaxel plus carboplatin in subjects with squamous cell non-small cell lung cancer (NSCLC).

• IRAS ID

  199608

• Contact name

  Mary O'Brien

• Contact email

  Mary.obrien@rmh.nhs.uk

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2014-003804-66

• Clinicaltrials.gov Identifier

  NCT02027428

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  Non-small cell lung cancer is (NSCLC) the most common type of lung cancer, accounting for 85% of all new cases. There are many different types of NSCLC and about 25% to 30% of all lung cancers affect squamous cells and are known as squamous cell carcinomas. Although there are several treatment options to initially help slow down or stop worsening of the disease, treatment options for long term maintenance in squamous NSCLC is limited.

  nab-Paclitaxel is a chemotherapy drug that has been approved for use in combination with carboplatin in several countries (e.g., US, EU, Japan, Argentina, Australia, New Zealand, Ecuador, Chile and Guatemala) as first line treatment for patients with NSCLC who are not candidates for curative surgery or radiation therapy.

  The purpose of this study is to test if nab-paclitaxel and best supportive care (BSC), when given after response with initial nab-paclitaxel and carboplatin induction therapy, is safe and can help to control the disease and increase the length of time people respond compared to BSC alone.

  Participants will be assigned in a 2:1 ratio into maintenance therapy into 1 of 2 treatment groups:
  • nab-Paclitaxel intravenous infusion on Days 1 and 8 of every 21 day treatment cycle plus BSC
  • BSC alone

  Study duration may be about 3 to 4 years, but the average amount of time is expected to be about 1 to 2 years. Participants will attend the clinic at least 30 times, followed by a 28 day follow up visit and a survival follow up phone call every 3 months. Procedures involved include: physical exam, vital signs, blood tests, ECGs, CT scans and archived tumour tissue samples.

  This study is sponsored by Celgene Corporation. Approximately 540 subjects from 110 sites worldwide will participate. Approximately 50 participants will be recruited in the UK.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  16/LO/1032

• Date of REC Opinion

  18 Jul 2016

• REC opinion

  Further Information Favourable Opinion