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.
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.
Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
Participants with squamous histology are excluded if there is a known tumor-activating epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) or c ros oncogene 1 (ROS1) gene rearrangement.
Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement.
Parallel
Pembrolizumab
Biological/VaccinePembrolizumab 200mg IV Infusion.
Carboplatin
DrugCarboplatin IV infusion AUC5 or 6 mg/mL•min and not exceeding 900mg.
Paclitaxel
DrugPaclitaxel 200 mg/m\^2 IV infusion.
Nab-paclitaxel
DrugNab-paclitaxel 100mg/m\^2 IV infusion.
Pemetrexed
DrugPemetrexed 500mg/m\^2 IV infusion.
HER3-DXd
Biological/VaccineHER3-Dxd 5.6mg/kg IV infusion.
Overall Response Rate (ORR)
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)
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
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.
Duration of Response (DOR)
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)
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)
OS is defined as the time from randomization to death due to any cause.
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Merck Sharp & Dohme LLC
Lead sponsor
Daiichi Sankyo
Collaborator
