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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03559049
Other study ID # UMCC 2018.033
Secondary ID HUM00142973
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 24, 2018
Est. completion date July 2027

Study information

Verified date January 2024
Source University of Michigan Rogel Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date July 2027
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be willing and able to provide written informed consent/assent for the trial. - Be =18 years of age on day of signing informed consent. - Have a life expectancy of at least 3 months. - Have a diagnosis of stage IV non-squamous NSCLC 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 (Appendix 15.1). - Demonstrate adequate organ function - Female subject of childbearing potential should have a serum pregnancy test within -28 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 as outlined in Section 6.3.3 for the course of the study through 180 days after the last dose of study medications. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. - Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section 6.3.3, starting with the first dose of study therapy through 180 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. - If the patient has archival tissue, this should be collected for correlative studies. If archival tissue does not exist, a new biopsy is not required 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pembrolizumab
200mg IV every 21 days
Pemetrexed
500mg/m^2 IV every 21 days
Carboplatin
AUC 5 IV every 21 days
Rucaparib
600mg PO, BID days 1-21 of each 21 day cycle

Locations

Country Name City State
United States The University of Michigan Rogel Cancer Center Ann Arbor Michigan
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (3)

Lead Sponsor Collaborator
University of Michigan Rogel Cancer Center Clovis Oncology, Inc., Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median duration of time from start of treatment to time of progression The primary endpoint is median progression free survival (PFS) which is defined as the median duration of time from the start of treatment to progression. Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. Up to 5 years
Secondary Median duration of time from the start of treatment until death The secondary endpoint is median overall survival (OS) which is defined as the median duration of time from the start of treatment until death. Up to 5 years
Secondary Response rate Percentage of patients who achieve a complete or partial response after at least one cycle of maintenance therapy with rucaparib and pembrolizumab. Response assessed by immune-related Response Evaluation Criteria in Solid Tumors (irRecist). Up to 5 years
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