Cancer vaccine study for unresectable stage III non-small cell lung cancer
A multi-center phase III randomized, double-blind placebo-controlled study of the cancer vaccine Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in non-small cell lung cancer (NSCLC) subjects with unresectable stage III disease to compare the survival duration of all randomized subjects by treatment arm.
Merck KGaA, Darmstadt, Germany
1,322 participants
Dec 1, 2006
Interventional
Conditions
Summary
This is a study of a cancer vaccine known as Stimuvax for treating non-small cell lung cancer (NSCLC) at stage 3, where this cannot be operated on surgically. Who is it for? You may be suitable for this study if: • You have stage 3 non-small cell lung cancer that cannot be operated on. • You have received primary platinum chemoradiotherapy. • The cancer is stable or responsive. Trial details Participants will be randomly divided into two groups. Four weeks after the last chemoradiation treatment, one group receives one infusion of cyclophosphamide followed by weekly subcutaneous vaccination with Stimuvax for 8 weeks and then injections are given once every six weeks until any progression of the cancer. The other group will receive a non-active compound. The study aims to monitor survival time and time to any progression of symptoms. Currently there is no standard prescribed treatment for these people following chemoradiotherapy. Stimuvax is designed to stimulate the immune system to respond to a protein found in many cancers including NSCLC. This trial will determine if Stimuvax has beneficial effects after participants cease chemoradiation.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Investigational arm: Pre-treatment: one intravenous infusion of cyclophosphamide (infusion of 300 mg/m2, determined by calculation of the subject's body surface area. A maximum dose of 600mg will be given). Primary treatment: weekly subcutaneous vaccinations with Stimuvax (subcutaneous injection of 1,000 µg) for 8 consecutive weeks. Maintenance treatment: vaccinations with Stimuvax (subcutaneous injection of 1,000 µg) at 6-week intervals. Subjects will be discontinued upon documented disease progression.
Locations(1)
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ACTRN12607000173493