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

Critères d'inclusion

• 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; • Locally advanced unresectable stage III or metastatic stage IV disease (defined as TNM, according to 8th edition) not eligible for curative surgery and/or definitive (curative intended) chemoradiotherapy; • No sensitizing EGFR mutation, METex14 skipping mutation, BRAF V600E mutation, ALK/ROS1/RET, NTRK1/2 gene rearrangements, HER2 mutations, amplifications detected in primary tumor or metastases; • Have not received prior systemic treatment for their metastatic NSCLC. Patients who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for nonmetastatic disease are eligible if the therapy was completed at least 12 months prior to the diagnosis of metastatic disease; • Patients with treated and stable CNS metastases are eligible, provided they meet the following criteria: • No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed • No stereotactic radiation or whole-brain radiation within 14 days prior to registration. • Patients with known HIV-infection, who are at low risk of AIDS-related outcomes, are eligible, provided they meet the following criteria: • CD4+ T-cell counts are ≥ 350 cells/ųL • No history of AIDS-defining opportunistic infection within past 12 months • Patients have been on antiretroviral therapy (ART) for \> 4 weeks before registration and have a HIV viral load \< 400 copies/mL; • Patients with a prior malignancy and treated with curative intention are eligible if the treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence; • Measurable disease per RECIST v1.134); • Age ≥ 18 years; • Eastern Cooperative Oncology Group (ECOG) performance status 0-1; • Adequate bone marrow function as per local guidelines; • Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), AST and ALT ≤ 2.5 x ULN, or ≤ 5 x ULN under the assumption that abnormal values are a result of NSCLC; • Adequate renal function defined by stable estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2 (according to CKD-EPI formula); • Women of childbearing potential must use highly effective contraception (see chapter 9.4), are not pregnant or lactating and agree not to become pregnant during trial treatment and until 6 months after the last dose of investigational drug. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential. • Men agree not to donate sperm or to father a child during trial treatment and until 6 months after the last dose of investigational drug.