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

ConditionMetastatic NSCLC - Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70+
SponsorSwiss Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent as documented by signature

Histologically or cytologically confirmed NSCLC. Mixed histology with small-cell component is not allowed.

Metastatic or advanced or recurrent NSCLC without a curative-intent treatment option (surgery or chemo-radiotherapy).

PD-L1 <50% by local testing (SP 142 excluded)

Disqualifiers

Actionable genomic alteration for 1L treatment (EGFR, ALK, ROS1, RET, NTRK, MET Exon14 skipping). Testing is required for any NSQ-NSCLC or patients with SCC and a smoking history of ≤10py.

Prior systemic treatment for metastatic NSCLC.

Prior chemotherapy and/or immunotherapy in curative-intent treatment for locally advanced NSCLC in the past 6 months.

Oligometastatic treatment concept with induction systemic therapy and planned LAT to all lesions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cemiplimab

    Drug

    cemiplimab IV 350 mg, day 1

  • Carboplatin

    Drug

    carboplatin IV AUC 3 day 1

  • Pemetrexed & Gemcitabine

    Drug

    pemetrexed IV 300 mg/m2 day 1 gemcitabine IV 600 mg/m2 day 1, d8

  • Paclitaxel

    Drug

    paclitaxel IV 50 mg/m2 day 1, d8

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Experimental armExperimental treatment 4 interventions
Group B: Comparator armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

PFS is defined as time from randomization to confirmed tumor progression according to RECIST 1.1 or death due to any cause. Patients not experiencing an event will be censored at their last tumor assessment before starting a new anti-cancer treatment line (if any).

Time frame
From the date of randomization until the date of confirmed tumor progression according to RECIST 1.1 or death from any cause, assessed up to 1 year after end of treatment.

Secondary outcomes

1

Overall survival (OS)

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

Time frame
From the date of randomization until the date of death from any cause, assessed up to 1 year after end of treatment.
2

Objective response rate (ORR)

Objective response is defined as any complete response (CR) or partial response (PR) according to RECIST 1.1 criteria achieved during treatment. Patients without any tumor assessment or with non-evaluable response during treatment will be considered as failures for this endpoint

Time frame
From the date of randomization until the end of treatment, estimated up to 1 year after randomization.

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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