IRB #

STUDY00019556

Title

[NCI CIRB] S1900A - A Phase II Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRAC1/2 Mutation Stage IV or Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub Study)

Principal Investigator

Jeremy Cetnar

Study Purpose

The purpose of this study is to look at the toxicities and response associated with the use of Rucaparib in patients with Non-Small Cell Lung Cancer and have a positive biomarker for LOH or BRCA 1/2.

Medical Condition(s)

Non-Small Cell Lung Cancer

Eligibility Criteria

1- Patients must be assigned to S1900A. Biomarker eligibility defined as LOH high and/or deleterious BRCA 1/2 mutation.

2- No prior treatment with any PSRP inhibitor

3- Must be able to take oral medications

4- Must not have greater than/equal to grade 3 hypercholesterolaemia within 28 days prior to sub-study registration

5- must not have EGFR sensitizing mutations

6- no evidence of acute hepatitis or active/uncontrolled infection

7- must have progressed following the most recent line of therapy but must not have received any prior systemic therapy within 21 days of registration nor have plans for concurrent chemotherapy, immunotherapy, biologic or hormonal therapy

8- clinical and laboratory parameters per protocol section 5.c

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Patients will be on study for 5 years from the time of study entry through follow up.

Minors Included

No

Contact

Knight Information Line - trials@ohsu.edu or 503-494-1080

Sponsor

SWOG

Recruitment End

03/05/2021

Compensation Provided

No


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