A Phase 3 Veliparib plus Chemotherapy Study in Non-Squamous NSCLC
Research type
Research Study
Full title
A Randomised, Open-Label, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
IRAS ID
162696
Contact name
Alastair Greystoke
Contact email
Sponsor organisation
AbbVie Ltd.
Eudract number
2014-002565-30
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
Lung cancer is the leading cause of cancer-related mortality throughout the world. Most lung cancers are diagnosed at an advanced (spreading to surrounding tissue) or metastatic (affecting several parts of the body) stage. Patients with Non Small Cell Lung Cancer (NSCLC) that are treated with current standard therapy experience disease progression within 4-6 months, and survive just 10-12 months - representing a significant unmet medical need. 60% of NSCLC cases are “non-squamous” NSCLC.
Carboplatin and paclitaxel are approved chemotherapy drugs and are widely used as a “standard” treatment for advanced or metastatic non-squamous NSCLC. Veliparib is a “PARP inhibitor” that may make chemotherapy better at killing cancer cells, and earlier trials have suggested a beneficial effect.
In this study all patients will receive chemotherapy. Half the patients will receive carboplatin and paclitaxel plus veliparib and the other half will receive the investigator’s choice of platinum doublet chemotherapy (carboplatin/paclitaxel, cisplatin/pemetrexed, or carboplatin/pemetrexed). The trial will see which treatment is better at controlling the cancer, by measuring overall survival, progression-free survival and overall response rate. This is a Phase II, randomised, open-label, multicentre trial of current and former smokers.
Patients could benefit if tumour growth is inhibited, therefore improving their condition and survival time. Information gathered may help improved future treatment of the disease.
Patients will attend regular study visits at hospital and have up to 6 cycles of treatment. The effect of the treatments on the cancer will be checked by having scans, blood tests, checking for side effects and completing questionnaires. There are additional blood tests to see why some people respond better than others, and how long the drug remains in the body, and an optional genetics test.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1214
Date of REC Opinion
1 Dec 2014
REC opinion
Favourable Opinion