Non-small Cell Lung Cancer
Conditions
Keywords
Lung Neoplasms, Lung Cancer, Pulmonary Neoplasms, Pulmonary Cancer, Non-Small Cell Lung Carcinoma
Brief summary
Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.
Interventions
BIOLOGICALPembrolizumab
Pembrolizumab 200mg IV Infusion.
DRUGCarboplatin
Carboplatin IV infusion AUC5 or 6 mg/mL•min and not exceeding 900mg.
DRUGPaclitaxel
Paclitaxel 200 mg/m\^2 IV infusion.
DRUGNab-paclitaxel
Nab-paclitaxel 100mg/m\^2 IV infusion.
DRUGPemetrexed
Pemetrexed 500mg/m\^2 IV infusion.
BIOLOGICALHER3-DXd
HER3-Dxd 5.6mg/kg IV infusion.
Sponsors
Merck Sharp & Dohme LLC
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a multi site, rolling-arm study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Staging Manual Version 8. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization. * Has archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on ART. * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to treatment randomization.
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to ~ 5 years | ORR is defined as a confirmed complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR). |
| Number of Participants with Adverse Events (AEs) | Up to ~ 5 years | Adverse events are any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. |
| Number of Participants Discontinuing Study Drug Due to AEs | Up to ~ 2 years | Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | Up to ~ 5 years | For participants who demonstrate a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. |
| Progression-free Survival (PFS) | Up to ~ 5 years | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. |
| Overall Survival (OS) | Up to ~ 5 years | OS is defined as the time from randomization to death due to any cause. |
Countries
Chile, Greece, Hungary, Israel, Italy, Poland, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed