RecruitingPhase 3ACTRN12607000173493

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.


Sponsor

Merck KGaA, Darmstadt, Germany

Enrollment

1,322 participants

Start Date

Dec 1, 2006

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people with stage 3 non-small cell lung cancer (NSCLC) that cannot be removed by surgery and has not spread to distant parts of the body. After completing standard chemotherapy and radiation treatment (chemoradiotherapy), participants are randomly assigned to receive either a cancer vaccine called Stimuvax or a placebo (dummy injection). Stimuvax works by activating the immune system to attack a protein found on many cancer cells. The study measures how long people live and how long it takes for the cancer to progress. You may be eligible if: - You are 18 years of age or older - You have confirmed stage III non-small cell lung cancer that cannot be surgically removed - You have completed at least 2 cycles of platinum-based chemotherapy and at least 50 Gy of radiation - Your cancer is stable or responding to treatment (confirmed within 4 weeks before joining) - You finished chemoradiotherapy between 4 and 12 weeks before joining the study - Your general health status (ECOG) is 0 or 1 You may NOT be eligible if: - You have had any other lung cancer-specific treatment besides chemoradiotherapy - You have metastatic (spread) disease or fluid around the lungs - You have an autoimmune disease or a known immune deficiency - You have significant heart, liver, or kidney disease - You are pregnant, breastfeeding, or not using effective contraception Talk to your doctor about whether this trial might be right for you.

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

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)

United States of America

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ACTRN12607000173493