Phase
Condition
N/ATreatment
Pembrolizumab
Docetaxel
Acasunlimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participant has histologically or cytologically confirmed metastatic NSCLC (stageIV).
Participant has progressed on or after receiving:
One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapyconcomitantly) in the metastatic disease setting; OR
No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-basedchemotherapy sequentially, irrespective of the order) in the metastatic diseasesetting.
Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determinedprospectively on a tumor sample from the metastatic setting at a sponsor-designatedcentral laboratory.
Participant has measurable disease according to RECIST v1.1 as assessed by theinvestigator 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 testresults within 7 days of trial treatment.
Exclusion
Key Exclusion Criteria:
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 ratsarcoma virus (KRAS), BRAF mutations, and MET exon 14 skipping mutations/METamplification. NOTE: MET amplification testing is optional based on localavailability of the test.
Participants with known KRAS/BRAF mutations are eligible for the trial if theydo not have access to approved targeted therapies.
Participants with newly identified or known unstable or symptomatic central nervoussystem (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 trialtreatment.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
MHAT for women's health - Nadezhda, OOD
Sofia,
BulgariaActive - Recruiting
CHU Angers - Hôpital Larrey
Angers,
FranceActive - Recruiting
Hôpital Ambroise Paré
Boulogne Billancourt,
FranceActive - Recruiting
Hôpital Privé du Confluent
Nantes,
FranceActive - Recruiting
CHU Rennes - Hopital Pontchaillou
Rennes,
FranceActive - Recruiting
Nippon Medical School Hospital
Bunkyo-ku,
JapanActive - Recruiting
NHO Kyushu Cancer Center
Fukuoka-shi,
JapanActive - Recruiting
NHO Hokkaido Cancer Center
Hokkaido,
JapanActive - Recruiting
Cancer Institute Hospital of JFCR
Koto City,
JapanActive - Recruiting
NHO Nagoya Medical Center
Nagoya,
JapanActive - Recruiting
Miyagi Cancer Center
Natori-shi,
JapanActive - Recruiting
Okayama University Hospital
Okayama,
JapanActive - Recruiting
Osaka Medical and Pharmaceutical University Hospital
Osaka,
JapanActive - Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do
Korea, Republic ofActive - Recruiting
Chungbuk National University Hospital
Cheongju-si,
Korea, Republic ofActive - Recruiting
Chungbuk National University Hospital
Chungcheongbuk-do,
Korea, Republic ofSite Not Available
Keimyung University Dongsan Hospital
Daegu,
Korea, Republic ofActive - Recruiting
National Cancer Center Korea
Goyang-si,
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul,
Korea, Republic ofActive - Recruiting
Antoni van Leeuwenhoek
Amsterdam,
NetherlandsActive - Recruiting
Auxilio Mutuo Cancer Center
San Juan, 917
Puerto RicoActive - Recruiting
Pan American Oncology Trials, LLC
San Juan, 902
Puerto RicoActive - Recruiting
Barts Hospital
London,
United KingdomActive - Recruiting
Guy's Hospital
London,
United KingdomActive - Recruiting
Ocala Oncology Center P.L.
Ocala, Florida 34474
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40202
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Oncology Hematology West
Omaha, Nebraska 68124
United StatesActive - Recruiting
Clinical Research Alliance
Westbury, New York 11590
United StatesActive - Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee 37920
United StatesActive - Recruiting
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