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

No results posted yet for this study

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

cemiplimab IV 350 mg, day 1

DRUG

Carboplatin

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020065 on ClinicalTrials.gov