SAKK 19/24

Supplemental magnesium administration in patients with advanced non-small cell lung cancer (NSCLC) receiving chemo-immunotherapy (SAKK 19/24)

For people with advanced non-small cell lung cancer (NSCLC), the combination of chemotherapy and immunotherapy (chemo-immunotherapy) is the standard treatment. During chemotherapy, blood magnesium levels in most patients decrease, leading to low blood magnesium levels (hypomagnesemia). Magnesium is an essential mineral for many bodily functions and also plays a role in fighting cancer cells. Magnesium is necessary for the proper functioning of immune cells that fight cancer cells. Consequently, low blood magnesium levels may reduce the effectiveness of cancer treatment. This study aims to determine whether supplemental magnesium administration in people receiving chemo-immunotherapy for advanced NSCLC can improve the effectiveness of this treatment. We also want to determine whether supplemental magnesium is well tolerated.

Disease being studied
Advanced non-small cell lung cancer

Treatment Evaluated in the Study
Each participant will receive the standard chemo-immunotherapy used to treat advanced NSCLC. Participants will be randomly assigned to one of two groups:

Participants in Group 1 will receive magnesium via infusion in addition to chemo-immunotherapy.
Participants in Group 2 will receive a placebo via infusion in addition to the chemoimmunotherapy. A placebo is a dummy medication that contains no active ingredient.

Starting at the beginning of the study treatment, each participant will take tablets daily at home (two tablets in the morning, at noon, and in the evening):

The tablets for participants in Group 1 will contain magnesium.
The tablets for participants in Group 2 will contain a placebo.

Study participants will not know whether they are taking magnesium or a placebo as part of their treatment.

The results from both groups will be compared.

Inclusion Criteria
Participants in the study must meet various requirements. Here are the most important ones:

Age: at least 18 years old.
The participant is scheduled to receive chemo-immunotherapy.
To date, the participant has not received any drug treatment for their advanced lung cancer.

Exclusion Criteria

Not all people with advanced NSCLC are eligible to participate in the study. Here are some of the main criteria that prevent a person from participating in the study:

The person’s blood magnesium level is too high or too low.
The person has already received drug treatment for their advanced NSCLC.
Tests have revealed certain genetic changes in the tumor cells.

Tumors with such changes are best treated with active ingredients other than the drugs being studied.

Kliniken

Kantonsspital Baden AG
Kantonsspital Graubünden
Kantonsspital Olten - Solothurner Spitäler AG
Kantonsspital Winterthur
St. Claraspital AG
TZA Tumor Zentrum Aargau - Hirslanden Medical Center
Universitätsspital Basel

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