Actively Recruiting

Phase 2
Age: 70Years +
All Genders
NCT07020065

Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50%

Led by Swiss Cancer Institute · Updated on 2026-04-15

156

Participants Needed

17

Research Sites

229 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50%

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Confirmed diagnosis of non-small cell lung cancer without small-cell components
  • Metastatic, advanced, or recurrent NSCLC without curative treatment options
  • Tumor PD-L1 expression less than 50% by local testing
  • Age 70 years or older
  • ECOG performance status between 0 and 2
  • G8 screening score of 14 or less or unsuitable for full-dose chemotherapy
  • Life expectancy of at least 6 months
  • Prior malignancies treated with curative intent completed at least 2 years ago, except certain low-recurrence cancers
  • Patients with asymptomatic untreated or treated symptomatic brain metastases on low-dose corticosteroids
  • Adequate bone marrow, kidney, and liver function as defined by lab values
  • Men agree not to father a child or donate sperm during and for 6 months after treatment
Not Eligible

You will not qualify if you...

  • Presence of actionable genomic alterations for first-line treatment such as EGFR, ALK, ROS1, RET, NTRK, MET Exon14 skipping
  • Previous systemic treatment for metastatic NSCLC
  • Chemotherapy or immunotherapy for locally advanced NSCLC within the past 6 months
  • Planned local ablative therapy after induction systemic therapy for oligometastatic disease
  • High tumor burden with risk of rapid progression as judged by investigator
  • Active autoimmune disease requiring treatment in the past 2 years except specified conditions
  • History of pneumonitis in the past 5 years
  • Systemic corticosteroid use above 10 mg/day or other immunosuppressants within 7 days before first dose
  • Infection requiring hospitalization or IV antibiotics within 2 weeks prior to first dose
  • Uncontrolled HIV, hepatitis B or C infections
  • Receipt of live vaccine within 4 weeks before treatment
  • COVID-19 vaccination within 1 week before planned treatment start or incomplete vaccination schedule
  • Organ transplant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

HFR Fribourg

Fribourg, Villars-sur-Glâne, Switzerland, 1752

Actively Recruiting

2

Kantonsspital Aarau

Aarau, Switzerland, CH-5001

Actively Recruiting

3

Kantonsspital Baden

Baden, Switzerland, 5404

Actively Recruiting

4

Universitätsspital Basel

Basel, Switzerland, 4031

Actively Recruiting

5

Inselspital

Bern, Switzerland, 3010

Actively Recruiting

6

Kantonsspital Baselland

Bruderholz, Switzerland, 4101

Actively Recruiting

7

Kantonsspital Graubuenden

Chur, Switzerland, CH-7000

Actively Recruiting

8

Spital Thurgau AG - Kantonsspital Frauenfeld

Frauenfeld, Switzerland, 8501

Actively Recruiting

9

Hôpitaux Universitaires de Genève

Geneva, Switzerland, 1211

Actively Recruiting

10

Kantonsspital Olten - Solothurner Spitäler

Olten, Switzerland, 4600

Actively Recruiting

11

Kantonsspital - St. Gallen

Sankt Gallen, Switzerland, CH-9007

Actively Recruiting

12

Hôpital du Valais - Sion

Sion, Switzerland, 1951

Actively Recruiting

13

Spital Thun

Thun, Switzerland, 3600

Actively Recruiting

14

EOC Istituto Oncologico della Svizzera Italiana (IOSI)

Viganello, Switzerland, 6962

Actively Recruiting

15

Kantonsspital Winterthur

Winterthur, Switzerland, 8401

Actively Recruiting

16

KSW Kantonsspital Winterthur

Winterthur, Switzerland, 8401

Actively Recruiting

17

Stadtspital Zürich Triemli

Zurich, Switzerland, 8063

Actively Recruiting

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Research Team

G

Gisela Müller

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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