Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCatalYm GmbH
About this trial
This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC.
Demonstrated absence of actionable mutations (e.g., EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
Measurable disease determined by the local site Investigator/radiology by their assessment per RECIST v1.1.
Have not received prior systemic treatment for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease and did not contain any PD 1/PD L1 directed CPI therapy.
Disqualifiers
Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the predominant cell type) or presence of small cell lung cancer elements (ineligibility independent of percentage).
Any acute or chronic major tissue injury that may require maintained GDF 15 function for tissue protection as per Investigator assessment (diagnosed with myocardial infarction, or liver, kidney or other major organ failure, all within < 3 months prior to planned treatment start).
Major surgery (defined as a surgery which requires general anesthetic and/or involves opening of body cavities), within 4 weeks of the first dose of study drug.
Received potentially curative radiation therapy to the lung that is > 30 Gy within 6 months prior to the first dose of study drug.
Trial design
Design model
Parallel
Treatments tested in this trial
Visugromab
Biological/VaccineParticipants receive Visugromab (recommended dose) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.
Matching placebo for visugromab
DrugParticipants receive Matching Placebo intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.
Pembrolizumab 200 mg Q3W
Biological/VaccineParticipants receive Pembrolizumab 200 mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion.
Pemetrexed 500 mg/m^2
DrugParticipants receive Pemetrexed 500 mg/m\^2 IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.
Carboplatin AUC 5
DrugParticipants receive Carboplatin target dose Area Under Curve (AUC) 5 (maximum dose 750 mg) on Day 1 of each 21-day cycle for four cycles.
Treatment groups
107 Participants
are divided into 2 treatment groupsGroup A: Visugromab (CTL-002) + Immunochemotherapy Combination (SoC treatment) - Arm AExperimental treatment 4 interventions
Group B: Placebo + Immunochemotherapy Combination (SoC treatment) - Arm BActive comparator 4 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator at any time during the core trial period
Time frame
up to 24 monthsSecondary outcomes
1
Adverse Events
Incidence, type and severity of adverse events, treatment emergent adverse events, treatment-related adverse events and serious adverse events
Time frame
up to 27 months2
CR rate
Complete response rate
Time frame
up to 24 months3
PR rate
Partial response rate
Time frame
up to 24 months4
DOR
Duration of response
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov