Lung Cancer Clinical Trial
Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer
This study is a multi-center, Phase I/II, single arm trial to assess the safety and efficacy of the combination of oral rucaparib plus intravenous pembrolizumab as maintenance therapy in patients with stage IV non-squamous non-small cell lung cancer (NSCLC) without progressive disease (PD), as confirmed on CT scans, after induction therapy with carboplatin/pemetrexed/pembrolizumab (CPP) triplet therapy.
Have a life expectancy of at least 3 months
Have a histologically confirmed diagnosis of stage IV non-squamous NSCLC (non-small cell lung cancer) whose tumors do not have an epidermal sensitizing growth factor (EGFR) mutation or BRAF mutation or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1 and have at least one measurable lesion based on RECIST v1.1
Have a performance status of 0 or 1 on the ECOG Performance Scale (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death)
Demonstrate adequate organ function
Female subjects of childbearing potential should have a serum pregnancy within 14 days of enrollment and 72 hours prior to receiving the first dose of study medications.
Female subjects of childbearing potential must be willing to use a highly effective method of contraception for the course of the study through 180 days after the last dose of study medications.
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study therapy.
Adequate tissue sample for correlative studies
Received previous systemic therapy for stage IV NSCLC
Received radiation to the lungs >30Gy ≤6 months of enrollment
Received palliative radiation within 7 days of enrollment
Had prior treatment with any other anti-PD-1, PD-L1, or PD-L2 agent or an antibody targeting other immune-regulatory receptors or mechanisms
Received prior treatment with a PARP inhibitor
Has a known history of prior malignancy except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has active autoimmune disease that has required systemic treatment within the past 2 years
Subjects requiring daily corticosteroids >10mg of prednisone (or its equivalent) would be excluded from the study.
Has evidence of interstitial lung disease or a history of non-infectious pneumonitis that required oral or intravenous glucocorticoids to assist with management
Has an active infection requiring systemic therapy
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment
Has a diagnosis of immunodeficiency (including Human Immunodeficiency Virus (HIV) or acquired immunodeficiency (AIDS)-related illness) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment
Has a known history of active TB (Bacillus Tuberculosis)
Has known active Hepatitis B or Hepatitis C
Has received a live vaccine within 30 days of enrollment
A medical condition that requires daily systemic corticosteroids, greater than the equivalent of 10mg of prednisone
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