NCT02423590

Study of Gemcitabine/Carboplatin First-line Chemotherapy +/- Apatorsen in Advanced Squamous Cell Lung Cancers

A Phase II Randomised, Open-label Study of Gemcitabine/Carboplatin First-line Chemotherapy in Combination With or Without the Antisense Oligonucleotide Apatorsen (OGX-427) in Advanced Squamous Cell Lung Cancers

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being carried out to see if a new drug called Apatorsen in combination with standard gemcitabine/carboplatin chemotherapy is effective in treating squamous cell lung cancer. This study is part of a research project for collecting information about the effectiveness and safety of Apatorsen when used with gemcitabine/carboplatin chemotherapy. The main purpose of this study is to see if Apatorsen, when combined with gemcitabine/carboplatin, is an effective treatment for squamous cell lung cancer. Recent research has found that a protein called Hsp27 can help cancer cells protect themselves against the effects of cancer treatments. Hsp27 is only found in some lung cancers but when it is present, cancer drugs might not work as well as they would without Hsp27 being present. Blocking the action of Hsp27 or removing Hsp27 from cancer cells with Apatorsen may slow down or stop the cancer growing. This study will therefore look at the relationship between the Hsp27 levels in tumour and blood and the effect of the treatment. The development of Apatorsen is intended to provide a new treatment option for patients with cancer. Apatorsen may also make the cancer more sensitive to gemcitabine and carboplatin and so make this chemotherapy treatment more effective.

Detailed description

This is an open-label, multicentre, 2-arm randomised phase II trial of gemcitabine/carboplatin + Apatorsen (OGX-427) versus gemcitabine/carboplatin alone in patients with previously untreated advanced squamous cell lung cancers. Patients will be randomised (1:1) to one of the two treatment arms: * Gemcitabine/carboplatin * Gemcitabine/carboplatin + Apatorsen (OGX-427) Randomisation will be stratified by the following criteria: * Stage (IIIB versus IV versus recurrent disease) * Performance status (0 or 1 versus 2) Gemcitabine/carboplatin chemotherapy will be continued for 4-6 cycles unless there is evidence of unacceptable toxicity, disease progression, or if the patient requests that study treatment be discontinued or to be withdrawn from the study. If chemotherapy is discontinued prior to disease progression, patients in the combination arm should be continued on Apatorsen (OGX-427) single agent therapy until disease progression unless there is evidence of unacceptable toxicity, patient withdrawal of consent or termination of the study, whichever occurs first. All patients will be followed for disease progression. Tumour evaluations will be performed before the initiation of treatment and every 6 weeks during and after completion of chemotherapy. Once disease progression is documented, patients will enter a Survival Follow-up Period during which data will be collected every two months regarding further cancer therapy, secondary malignancy and survival status. The study will also assess the relationship between the anticipated anti-tumour activity of the treatment regimen and biological characteristics of patients' tumours at baseline.

Conditions

• Squamous Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Apatorsen (OGX-427)	Apatorsen (OGX-427) is a second generation antisense oligonucleotide designed to bind to Hsp27 mRNA
DRUG	Gemcitabine	Gemcitabine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Gemcitabine is classified as an antimetabolite
DRUG	Carboplatin	Carboplatin is an anticancer drug ("antineoplastic" or "cytotoxic") chemotherapy drug. Carboplatin is classified as an "alkylating agent."

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-05-01
• Completion: 2018-06-01
• First posted: 2015-04-22
• Last updated: 2017-08-22

Locations

20 sites across 1 country: United Kingdom