Last updated 9 days ago

Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)

702 patients around the world
Available in Puerto Rico, Chile, Brazil, Argentina, United States
The goal of this trial is to determine the efficacy and safety of acasunlimab (an experimental antibody also known as GEN1046 or DuoBody® PDL1x4-1BB) in combination with pembrolizumab (an antibody known as KEYTRUDA®) compared to that of docetaxel (a standard of care chemotherapy). During the trial, the participant's quality of life will also be evaluated using industry-standard scales of measurement. To be eligible, participants must have: 1. non-small cell lung cancer that has metastasized (spread) 2. tumors that are positive for the PD-L1 protein (a biomarker that may be predictive of response to therapy) 3. been previously treated with a PD-1/PD-L1-inhibitor and a platinum-containing cancer therapy administered in combination or sequentially (irrespective of the order). Other eligibility criteria will also apply. Participants will be assigned to 1 of 2 active therapies, also known as treatment arms, as follows: - Acasunlimab (100 milligrams [mg]) and pembrolizumab (400 mg) once every 6 weeks (Q6W), or - Docetaxel 75 milligrams per meter squared (mg/m^2) once every 3 weeks (Q3W). The estimated trial duration for a participant will vary but may be up to 5 years, consisting of: - An optional 3-month pre-screening period - A 28-day screening period - Up to 2 years of treatment - A 90-day safety follow-up period - Post-treatment follow-up.
Genmab
16Research sites
702Patients around the world

This study is for people with

Lung cancer
Non-small cell lung carcinoma

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV with known subtype).
Participant has progressed radiographically on or after receiving:.
One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the metastatic disease setting.
No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the metastatic disease setting.
Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the metastatic setting at a sponsor-designated central laboratory.
Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.
Participant has a life expectancy of ≥3 months.
Participant must have adequate organ and bone marrow function, per laboratory test results within 7 days of trial treatment.
Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten rat sarcoma virus (KRAS), B-Raf proto-oncogene (BRAF) mutations, and MET proto-oncogene; receptor tyrosine kinase (MET) exon 14 skipping mutations/MET amplification.
Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to approved targeted therapies.
Participants with newly identified or known unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
Prior treatment with docetaxel for NSCLC.
Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.

Sites

Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Dorrego 269, La Rioja
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Av. Ipiranga, 6690 - 4º andar - Partenon, Porto Alegre - RS, 90610-001, Brazil
Hospital Erasto Gaertner
Recruiting
R. Dr. Ovande do Amaral, 201 - Jardim das Américas, Curitiba - PR, 81520-060, Brazil
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Recruiting
Av. Príncipe de Gales, 821 - Vila Principe de Gales, Santo André - SP, 09060-650
Oncoclínicas
Recruiting
Rio De Janeiro, 22250-905
Hospital Ernesto Dornelles
Recruiting
Av. Ipiranga, 1801 - Azenha, Porto Alegre - RS, 90160-092
Oncoclínicas do Brasil Serviços Médicos
Recruiting
R. Santa Catarina, 472 - Centro, Belo Horizonte - MG, 30170-081, Brazil
Hospital Sírio-Libanês
Recruiting
Rua Dona Adma Jafet, 91 - Bela Vista, São Paulo - SP, 01308-050, Brazil
Centro Paulista de Oncologia
Recruiting
Avenida Brigadeiro Faria Lima, 4300 - Vila Olímpia, São Paulo - SP, 04538, Brazil
A Beneficência Portuguesa de São Paulo
Recruiting
São Paulo
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