University College London | Centre for Clinical Microbiology
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About
The purpose of this trial is to investigate the safety and efficacy of acasunlimab (also known as GEN1046) as monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer who have progressed during or after treatment of previous standard of care
Full description
This trial is a randomized, open-label trial evaluating the safety and efficacy of acasunlimab (GEN1046) as monotherapy and in combination therapy with pembrolizumab.
The trial consists of two parts; a safety phase and an extension phase. The extension phase will be initiated once the safety phase is completed.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Documentation of known EGFR, KRAS, RET, ROS1, BRAF mutations, NTRK gene infusions, RET arrangement, ALK gene rearrangements, high-level MET amplification, or METex 14 skipping. Note: Subjects harboring such mutations, gene rearrangements or amplifications may be enrolled in the trial, if subjects have received prior approved targeted therapy for such mutations, the subject may still be eligible for this trial.
Treatment with an anti-cancer agent within 28 days prior to acasunlimab administration.
Any investigational agent for the treatment of stage 4 NSCLC.
Radiotherapy within 14 days prior to first dose of acasunlimab. Note: palliative radiotherapy will be allowed for local pain control under certain conditions.
Chronic systemic immunosuppressive corticosteroid doses, ie, prednisone >10 mg daily or a cumulative dose >150 mg prednisone within 14 days before the first acasunlimab administration.
Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Subject has contraindications to the use of pembrolizumab per local prescribing information.
Subject has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis (interstitial lung disease).
Ongoing or active infection requiring intravenous treatment with anti-infective therapy or any ongoing systemic inflammatory condition requiring further diagnostic work-up or management during screening.
Symptomatic congestive heart failure (grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia.
Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management.
Ongoing or recent (within 6 months) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
Subject has a known history of any of the following:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
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Interventional model
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125 participants in 3 patient groups
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Genmab A/S Trial Information
Data sourced from clinicaltrials.gov
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