Rucaparib for Non-Small Cell Lung Cancer

Recruiting at 949 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: SWOG Cancer Research Network

Must not be taking: PARP inhibitors

Disqualifiers: EGFR mutations, Active infection, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days per cycle, repeated

64 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jonathan W Riess

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with stage IV or recurrent non-small cell lung cancer that have high genomic loss of heterozygosity (LOH) or harmful BRCA1/2 mutations. Participants must be able to take oral medications, not have certain liver conditions, infections, or recent major surgeries. They should not have had prior treatment with PARP inhibitors and must agree to use effective contraception if of reproductive potential.

Inclusion Criteria

I am not planning to receive any cancer treatments other than this study's treatment.

My liver function tests are within the required range.

I do not have severe heart disease or recent serious heart issues.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rucaparib orally twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

21 days per cycle, repeated

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 3 months for 1 year, then every 6 months for up to 3 years.

Up to 3 years

Treatment Details

Interventions

• Rucaparib

Trial Overview The trial is testing the effectiveness of Rucaparib, a drug designed to block enzymes needed for tumor growth in patients with specific genetic profiles related to lung cancer. It's a phase II study which means it focuses on the drug's efficacy and side effects.

Participant Groups

Group I: Treatment (rucaparib) Experimental Treatment 1 Intervention

Patients receive rucaparib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+