Rescue Medications: Participants receive rescue medication at the investigator's discretion for prevention of nausea and vomiting, per approved product label. Recommended rescue medications are histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent), 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist and corticosteroid.
Study summary
Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:
* About the safety of MK-1084 and if people tolerate it when taken with other treatments
* How many people have the cancer respond (get smaller or go away) to the treatments
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
* Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations
* Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy
* Has provided tumor tissue for biomarker analysis from an archival sample or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has evidence of any leptomeningeal disease
* Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization
* Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or current ILD, or suspected ILD
* Has an active infection requiring systemic therapy
* Has not adequately recovered from major surgery or has ongoing surgical complications
Primary outcome measure(s)
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) — Up to 42 days DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 42 days) that results in a change to a given dose or a delay in initiating the next treatment.
Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 63 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 62 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.
Objective Response Rate (ORR) — Up to approximately 63 months ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Trial sites (28)
Facility
City
Region
Status
Clermont Oncology Center ( Site 0041)
Clermont
Florida
Recruiting
University of Illinois Hospital & Health Sciences System ( Site 0044)
Chicago
Illinois
Recruiting
Providence Portland Medical Center ( Site 0043)
Portland
Oregon
Recruiting
Providence Oncology and Hematology Care Clinic - Westside ( Site 0059)
Portland
Oregon
Recruiting
Hospital São Lucas da PUCRS ( Site 0283)
Porto Alegre
Rio Grande do Sul
Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282)
Barretos
São Paulo
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286)
São José do Rio Preto
São Paulo
Recruiting
Hospital Paulistano ( Site 0280)
São Paulo
São Paulo
Recruiting
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162)
Santiago
Region M. de Santiago
Recruiting
FALP ( Site 0161)
Santiago
Region M. de Santiago
Recruiting
Bradfordhill ( Site 0160)
Santiago
Region M. de Santiago
Recruiting
Guangdong Provincial People s Hospital ( Site 0300)
Guangzhou
Guangdong
Recruiting
UniversitaetsklInikum Tuebingen ( Site 0192)
Tübingen
Baden-Wurttemberg
Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)
Athens
Attica
Recruiting
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0205)
Athens
Attica
Recruiting
Papageorgiou General Hospital of Thessaloniki ( Site 0206)
N.Efkarpia
Thessaloniki
Recruiting
Queen Mary Hospital ( Site 0230)
Hong Kong
Hong Kong
Recruiting
Hong Kong United Oncology Centre ( Site 0232)
Jordan
Hong Kong
Recruiting
Prince of Wales Hospital ( Site 0231)
Shatin
Hong Kong
Recruiting
Shaare Zedek Medical Center ( Site 0186)
Jerusalem
Israel
Recruiting
Meir Medical Center ( Site 0181)
Kfar Saba
Israel
Recruiting
Sheba Medical Center ( Site 0180)
Ramat Gan
Israel
Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0176)
Meldola
Forli-Cesena
Recruiting
Severance Hospital, Yonsei University Health System ( Site 0080)
Seoul
South Korea
Recruiting
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
Hospitalet
Barcelona
Recruiting
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0091)
Pozuelo de Alarcón
Madrid
Recruiting
Hospital Clinic de Barcelona ( Site 0092)
Barcelona
Spain
Recruiting
Hospital Universitario Virgen Macarena ( Site 0093)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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