Health TrialsbyHealthPanel

Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC)

ConditionMetastatic NSCLC - Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwiss Cancer Institute

About this trial

This study investigates whether adding magnesium to the standard chemo-immunotherapy for advanced non-small cell lung cancer (NSCLC) can improve treatment outcomes. Magnesium is important for immune function, and low levels during chemotherapy are common. Participants are randomly assigned to receive either magnesium or a placebo, both as infusions and tablets. Neither the participants nor the doctors know who receives which treatment. The study compares the two groups to see if magnesium helps and how well it is tolerated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures;

Histologically or cytologically confirmed diagnosis of NSCLC (adeno-, squamous-, large cell carcinoma or NSCLC not otherwise specified);

Patients planned for systemic first-line therapy with a combination of a carboplatin-based doublet chemotherapy and a PD-1 / PD-L1 targeting immune checkpoint inhibitor;

Patients not eligible for immune checkpoint inhibitor monotherapy irrespective of PD-L1 expression;

Disqualifiers

Plasma magnesium concentration < 0.4 mmol/l or > 1.2 mmol/L

Treatment with any anti-cancer therapy within 21 days prior to registration (excluding hormonal therapy or anti-cancer surgery). Any previous anti-cancer therapy must have been administered with curative intent;

Treatment with radiotherapy within 14 days prior to registration (except for local pain control);

Patients planned for cisplatin-based chemo-immunotherapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnesiocard

    Drug

    2.5 mmol film-coated tablets in addition to standard first line therapy

  • Magnesium Diasporal

    Drug

    4 mmol IV formulation in addition to standard first line therapy

  • Microcrystalline cellulose

    Other intervention

    Placebo film-coated tablets corresponding to Magnesiocard in addition to standard first line therapy

  • Isotonic saline solution 0.9%

    Other intervention

    Placebo for injection corresponding to Magnesium Diasporal in addition to standard first line therapy

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: MagnesiumExperimental treatment 2 interventions
Group B: PlaceboActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Primary endpoint of Phase II part: Progression-free survival (PFS)

PFS defined as time from randomization to progression according to RECIST 1.1 criteria or death. Patients not experiencing an event will be censored at the date of the last available assessment before initiation of a new anti-cancer treatment, if any.

Time frame
From randomization to PD or death, up to 10 years
2

Primary endpoint of Phase III part: Overall survival (OS)

OS defined as the time from randomization until death due to any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

Time frame
From randomization to PD or death, up to 10 years

Secondary outcomes

1

Toxicity - Intermediate endpoint for the adaptive decision to expand, or not, into a Phase III

Immune related adverse events (irAEs) ≥ Grade 3 according to NCI CTCAE v5.0

Time frame
All adverse events: from baseline until end of treatment, deaths: until end of follow-up, up to 10 years
2

Number of participants discontinued any treatment component.

Tolerability - Intermediate endpoint for the adaptive decision to expand, or not, into a Phase III. Discontinuation of any treatment component (chemotherapy and/or immunotherapy) within the first 4 cycles of treatment

Time frame
from baseline until end of treatment, deaths: until end of follow-up, up to 10 years
3

Event-free survival (EFS)

EFS is defined as time from registration to one of the following events, whichever occurs first: * Relapse or progression according to RECIST 1.1 criteria * Second tumor * Death due to any cause Patients not experiencing an event will be censored at the date of the last available assessment before initiation of a new anti-cancer treatment, if any.

Time frame
From randomization to PD, 2nd tumor or death, up to 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Swiss Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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