Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50%
NCT07020065 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2026-04-15
Summary
Metastatic non-small cell lung cancer is often treated with a combination of chemotherapy and immunotherapy. In patients over the age of 70, some are already in poor health and frail, requiring assistance with daily activities, for example. Older and/or frail individuals often do not tolerate standard-dose chemotherapy well, and their risk of side effects is higher than that of younger patients.
For this reason, the SAKK 18/24 study is investigating how effective and safe chemotherapy is in patients over 70 years of age when the chemotherapy drugs are administered at lower doses than usual. The aim of the study is to find a potentially effective and well-tolerated treatment for older people with metastatic non-small cell lung cancer.
Conditions
- Metastatic NSCLC - Non-Small Cell Lung Cancer
Interventions
- DRUG
-
cemiplimab IV 350 mg, day 1
- DRUG
-
carboplatin IV AUC 3 day 1
- DRUG
-
Pemetrexed & Gemcitabine
pemetrexed IV 300 mg/m2 day 1 gemcitabine IV 600 mg/m2 day 1, d8
- DRUG
-
paclitaxel IV 50 mg/m2 day 1, d8
Sponsors & Collaborators
-
Swiss Cancer Institute
lead OTHER
Principal Investigators
-
Laetitia Mauti, MD · Kantonsspital Winterthur KSW
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-10
- Primary Completion
- 2028-09-30
- Completion
- 2030-09-30
Countries
- Switzerland
Study Locations
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