Rucaparib for Non-Small Cell Lung Cancer

No longer recruiting at 966 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of rucaparib, a targeted therapy, against advanced non-small cell lung cancer with specific genetic changes in the BRCA1 or BRCA2 genes. Rucaparib blocks certain enzymes that cancer cells need to grow. Individuals with stage IV non-small cell lung cancer and specific genetic changes, such as high genomic loss of heterozygosity or harmful BRCA1/2 mutations, may qualify. Participants should not have previously used similar drugs and must be able to take pills. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot receive any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment while on the study. Non-cancer-related medications, like insulin for diabetes, are allowed.

Is there any evidence suggesting that rucaparib is likely to be safe for humans?

Research has shown that rucaparib has been tested in people with certain types of cancer, providing some safety information. In one study, the most common serious side effects included low red blood cell count (anemia) in 22% of patients, low white blood cell count (lymphopenia) in 8%, tiredness in 8%, and liver issues in 5%. These findings suggest that while risks exist, many people tolerate the treatment reasonably well.

Rucaparib targets specific proteins that aid cancer cell growth. Previous tests in other cancers offer some reassurance about its safety. However, all treatments can have side effects, and individuals may experience them differently. Consulting a doctor can provide more insight into these potential effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for non-small cell lung cancer, such as chemotherapy and immunotherapy, rucaparib is unique because it targets a specific enzyme involved in DNA repair. This enzyme, called PARP (poly ADP-ribose polymerase), helps cancer cells fix their damaged DNA to keep growing. By inhibiting PARP, rucaparib may prevent cancer cells from repairing themselves, potentially leading to their death. Researchers are excited about rucaparib because it offers a new way to attack cancer cells, possibly improving outcomes for patients who don't respond well to existing treatments.

What evidence suggests that rucaparib might be an effective treatment for non-small cell lung cancer?

Research has shown that rucaparib, a type of medication called a PARP inhibitor, might help treat non-small cell lung cancer (NSCLC) by stopping certain enzymes that aid cancer cell growth. Studies have found that using PARP inhibitors like rucaparib can extend the lives of some patients with NSCLC. In animal studies, rucaparib treatment reduced tumor size and slowed cancer cell growth. Some patients have experienced side effects such as anemia, which involves having too few healthy red blood cells, but these side effects are usually manageable. While more research is needed, early results are promising for rucaparib as a potential treatment for NSCLC. ^{1 2 4 6 7}

Who Is on the Research Team?

Jonathan W Riess

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.9024

A phase II study of rucaparib in patients with high genomic ...

The most frequent grade ≥3 adverse events were anemia (22%), lymphopenia (8%), fatigue (8%) and transaminitis (5%). Conclusions: S1900A failed ...

2.

jto.org

jto.org/article/S1556-0864(23)01356-4/fulltext

P2.06-08 Phase I/II Study of Rucaparib and ...

Here we report the early results of the 14 patients who received at least one cycle of maintenance rucaparib and pembrolizumab. The median age was 59 and 64% ...

3.

cco.amegroups.org

cco.amegroups.org/article/view/120009/html

Efficacy and safety of PARP inhibitor in non-small cell lung ...

The use of iPARPs in NSCLC may lead to increased survival in several selected patients, and their use may become a standard in the coming years.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9916668/

Attenuation of Tumor Burden in Response to Rucaparib ...

In lung tumors of rucaparib-treated mice compared to non-treated animals, tumor burden, PARP activity, and cell proliferation decreased, while DNA damage, TUNEL ...

5.

jto.org

jto.org/article/S1556-0864(21)02479-5/fulltext

OA07.03 A Phase II Study of Frontline Rucaparib + ...

The primary outcome is median progression free survival. Secondary endpoint includes objective responses assessment and toxicity profile per CTCAE 5.0.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8236452/

Pharmacokinetics and safety of rucaparib in patients with ...

Rucaparib induces cytotoxicity in tumor cells with homologous recombination deficiency through a mechanism known as synthetic lethality, wherein ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04276376

Study Details | NCT04276376 | Efficacy and Safety of the ...

The manufacturer (Clovis) supplying Rucaparib has gone bankrupt and is no longer able to fund the trial and supply the product.