Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Collaborators: Clovis Oncology, Inc.; Merck Sharp & Dohme Corp.
• Treatments: Carboplatin; Pembrolizumab; Pemetrexed; Rucaparib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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