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Phase 2 N=59 Treatment

Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

Deleterious BRCA1 Gene Mutation · Deleterious BRCA2 Gene Mutation · Loss of Heterozygosity · Lung Non-Small Cell Squamous Carcinoma · Recurrent Large Cell Lung Carcinoma

Enrolled (actual)
59
Serious AEs
54.2%
Results posted
Oct 2022
Primary outcome: Primary: Overall Response Rate — 8; 12 Percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Rucaparib (Drug)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
SWOG Cancer Research Network
Primary completion
Jan 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Response Rate
8; 12
SECONDARY
Investigator-Assessed Progression-Free Survival (IA-PFS)
2.9; 3.5
SECONDARY
Overall Survival (OS)
8.2; 7.8
SECONDARY
Duration of Response (DoR)
NA; 14.9
SECONDARY
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
2; 1; 13; 1; 1; 1

Summary

This phase II Lung-MAP trial studies how well rucaparib works in treating patients with genomic loss of heterozygosity (LOH) high and/or deleterious BRCA1/2 mutation stage IV non-small cell lung cancer or that has come back. Rucaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

  • Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
  • Patients must be assigned to S1900A. S1900A biomarker eligibility defined as LOH high and/or deleterious BRCA1/2 mutation is as follows using the Foundation Medicine Inc (FMI) tissue- assay:
  • LOH; alteration type: loss of heterozygosity (LOH); eligible alteration: Genomic LOH >= 21%
  • BRCA; alteration type: homologous recombination deficiency (HRD); eligible alteration: Deleterious mutations in BRCA1 or BRCA2
  • Patients must not have had prior treatment with any PARP inhibitor, including rucaparib, talazoparib, veliparib, olaparib, or niraparib. For information and a list of PARP inhibitors, please consult the S1900A ? Poly Polymerase Inhibitors, Scott et al., 2015 JCO ref from the link on the S1900A protocol abstract page of the SWOG (http://swog.org) or CTSU (https://www.ctsu.org) websites.
  • Patients must be able to take oral medications.
  • Patients must not have a >= Grade 3 hypercholesterolaemia (defined by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]5) within 28 days prior to sub-study registration.
  • Patients must not have EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, and BRAF V600E mutation unless they have progressed following all standard of care targeted therapy.
  • Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection.
  • Patients with a known history of human immunodeficiency virus (HIV) seropositivity:
  • Must have undetectable viral load using standard HIV assays in clinical practice.
  • Must have CD4 count >= 400/mcL.
  • Must not require prophylaxis for any opportunistic infections (i.e., fungal, mycobacterium avium complex [mAC], or pneumocystis pneumonia [PCP] prophylaxis).
  • Must not be newly diagnosed within 12 months prior to sub-study registration.
  • Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy.
  • Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration. Patients must have recovered (= = 1,500/mcl (obtained within 28 days prior to sub-study registration)
  • Platelet count >= 100, 000 mcl (obtained within 28 days prior to sub-study registration)
  • Hemoglobin >= 9 g/dL (obtained within 28 days prior to sub-study registration)
  • Serum bilirubin = = 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration.
  • Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration.
  • Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
  • Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
  • Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study and 6 months after study completion. A woman is considered to be
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03845296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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