Comparison of Visugromab and Placebo in Combination with Immunochemotherapy (ICT) in Metastatic, Non-Squamous, Non-Small Cell Lung Cancer (NSCLC)

Zusammenfassung der Studie

The sponsor wants to find out how well Visugromab works in combination with immunochemotherapy (ICT) in newly diagnosed, metastatic (spread from the lung to other areas of the body) non-squamous, non-small cell lung cancer (NSCLC) (also referred to as 'lung cancer'). The ICT includes the medications Pembrolizumab (which helps the immune system fight cancer) and Carboplatin as well as Pemetrexed (which affects the growth of cancer cells). ICT is considered the current standard treatment for newly diagnosed non-squamous NSCLC in many countries. The aim of this study is to determine how safe, tolerable, and effective Visugromab + ICT is compared to Placebo + ICT. The study will also assess adverse events (side effects), measure Visugromab in the blood, evaluate changes in quality of life during the study, and examine tumor samples for potential markers. The study is divided into 2 parts (participants will only take part in one part): an open-label (i.e., it is known that Visugromab is being used) safety lead-in phase, where 2-3 different doses of Visugromab will be tested to determine which dose is safer and better tolerated (treatment duration max. 24 months). This is followed by a double-blind (i.e., neither the participants nor the investigator know whether Visugromab or placebo is being used), randomized (i.e., treatment is assigned randomly, like flipping a coin) part with a placebo. The treatment lasts up to 24 months, and study participation, including follow-up, lasts up to 4 years and 1 month. Participants in this study must be at least 18 years old and have newly diagnosed metastatic lung cancer that has not been treated systemically (affecting the whole body) and must have adequate function of various organs.

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Untersuchte Intervention

Interventions refer to all medications or treatments that participants will receive during the study, including both those under clinical investigation and those already available on the market. This study is divided into 2 parts: a safety lead-in phase and a subsequent randomized part. Participants will only take part in one part. The purpose of the safety lead-in phase is to assess the early safety and tolerability of the investigational drug (CTL-002) in combination with ICT. During this phase of the study, different doses of CTL-002 will be tested to determine which dose will be used in the randomized part. Participants in the safety lead-in phase of the study may receive 1 of 3 different doses of CTL-002 in combination with ICT. • Low Dose: Initially, 3-6 participants will receive the lower dose. If no relevant side effects occur during the observation phase and the dose is deemed safe, the next group of 3-6 participants will receive the higher dose. • High Dose: If the high dose is well tolerated and deemed safe by external experts, participants receiving the high dose will continue treatment for up to 2 years or until they withdraw from the study or until their condition worsens, whichever occurs first. Participants who initially received the lower dose will be switched to the higher dose if it is deemed safe. • Medium Dose: If the lower dose is safe but the higher dose is not well tolerated, participants who received the higher dose will be immediately switched to the lower dose. External experts may then decide to test a medium dose between the two already tested doses. Participants assigned to the medium dose (3-6 participants) will receive this until it is deemed unsafe, until participants decide to withdraw from the study, or until their condition worsens. Participants on the lower dose will be switched to the medium dose if it is deemed safe. If the medium dose is deemed unsafe, participants will be switched to a lower dose that is considered safer by external experts. The randomized part aims to compare the efficacy and safety of the CTL-002 dose determined in the safety lead-in phase and the placebo – each in combination with ICT. The placebo looks the same as CTL-002 but contains no active ingredient. Participants in the randomized part will be assigned randomly (like flipping a coin) in a ratio of 2:1 to receive either CTL-002 + ICT or placebo + ICT. This means that two-thirds of the participants will receive CTL-002 + ICT and one-third will receive placebo + ICT. This part of the study is 'double-blind.' 'Double-blind' means that neither the participants nor the doctors will know whether CTL-002 or the placebo is being administered. The idea is to minimize any influence on the results. Through randomization and double-blinding, the sponsor can objectively assess how well the investigational drug actually works and whether it is safe. In both parts, ICT includes Pembrolizumab i.v. as a 30-minute infusion, followed by Pemetrexed i.v. as a 10-minute infusion, followed by Carboplatin i.v. as a 15 to 60-minute infusion. All participants will receive oral folic acid, injections of vitamin B12, and 2 doses of dexamethasone (or an equivalent) to take before, on, and after the day of the ICT infusion. Blood and urine tests, heart health assessments, and body imaging will be conducted on participants throughout the study. Participation in the study lasts a maximum of 4 years and 1 month for each participant. The treatment part of the study will last up to 2 years, divided into cycles of approximately 3 weeks each. Depending on the study part, participants will be invited to 1-3 study visits in each cycle. A visit may last 6-8 hours. In the safety lead-in phase, participants will stay overnight in the hospital for safety observation after the first administration of CTL-002 and ICT. In all other cycles, no overnight stay in the hospital is planned after the infusions of the investigational drug and ICT.

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Untersuchte Krankheit(en)

Metastatic, Non-Squamous, Non-Small Cell Lung Cancer (NSCLC)

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Sponsor

CatalYm GmbH, Germany PSI CRO AG, CH-Zug

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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Ostschweiz EKOS

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Datum der Bewilligung durch die Ethikkommission

17.04.2025

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Ergebnisse der Studie