Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Recurrence

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Immune Checkpoint Inhibitors

Pembrolizumab

Antibodies, Bispecific

Immunoglobulins

Antineoplastic Agents, Immunological

Treatment with acasunlimab once every 21 days for the first 2 cycles and then every 42 days in subsequent cycles

Treatment with acasunlimab + pembrolizumab once every 21 days

Treatment with acasunlimab+ pembrolizumab once every 42 days

Acasunlimab will be administered intravenously (IV)

Acasunlimab

Genmab A/S Trial Information

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

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.

Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer

A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination Pembrolizumab Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor

ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per RECIST v1.1

DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v. 1.1 or death from any cause, whichever occurs first.

TTR will be measured as the time from first treatment to onset of initial response (CR or PR) as per RECIST v.1.1

PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v.1.1 or until death from any cause, whichever occurs first

Defined as time to death from of any cause

Incidence of treatment-emergent AEs as assessed by CTCAE v5.0. Laboratory parameters graded by CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer	NCT05117242	Non Small Cell ...	Acasunlimab Pembrolizumab	18 Years -	Genmab
Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer	NCT05117242	Non Small Cell ...	Acasunlimab Pembrolizumab	18 Years -	Genmab

Spots Global Cancer Trial Database for duobody®

Every month we try and update this database with for duobody® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for duobody®

Every month we try and update this database with for duobody® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for duobody® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.