What side effects are associated with this type of intervention?

Common treatments for lung cancer, including chemotherapy, immunotherapy, and targeted therapies, often come with a range of side effects. Chemotherapy can cause fatigue, nausea, increased risk of infection, and hair loss. Immunotherapy, such as pembrolizumab and nivolumab, may lead to immune-related adverse events like pneumonitis, colitis, and skin reactions. Targeted therapies, including PARP inhibitors like Niraparib, can cause fatigue, nausea, anemia, and increased liver function tests. It's important for patients to discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for lung cancer, including immunotherapies and targeted therapies. For instance, durvalumab, a PD-L1 antibody, is approved for unresectable stage III non-small cell lung cancer (NSCLC) following chemoradiotherapy. Additionally, fam-trastuzumab deruxtecan, a HER2-targeted antibody-drug conjugate, is approved for metastatic NSCLC with HER2 mutations. While Niraparib, a PARP inhibitor, is being studied for its efficacy in advanced PALB2 mutated tumors, there are no specific FDA approvals for PARP inhibitors in lung cancer treatment as of now.

What other types of research exist?

Promising alternatives to Niraparib for lung cancer patients include: 1) Durvalumab plus chemotherapy, which has shown improved progression-free survival in metastatic NSCLC. 2) Pembrolizumab monotherapy or in combination with chemotherapy, particularly for patients with PD-L1 expression. 3) Ramucirumab combined with docetaxel, which has demonstrated improved overall survival in the second-line setting. 4) Pyrotinib and Poziotinib, which are effective in HER2-mutant NSCLC. These treatments offer novel mechanisms of action and have shown efficacy in clinical trials.

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PARP Inhibitor

Niraparib for Cancer (PAVO Trial)

Phase 2

Waitlist Available

Research Sponsored by Tempus Labs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have tested positive for a pathogenic or likely pathogenic tPALB2 gene mutation using a CLIA-certified laboratory as described in the Next-Generation Sequencing (NGS) Laboratory Manual.

Participants must have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor(s).

Must not have

Participants with germline or somatic BRCA1 or BRCA2 mutations.

Participants who have received Poly (ADP-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing niraparib, a medication that helps stop cancer cells from repairing their DNA. It is aimed at patients with advanced or metastatic solid tumors who have a specific genetic mutation called tPALB2. By blocking a protein involved in DNA repair, niraparib may help slow down or stop the growth of these tumors. Niraparib has been used successfully in treating ovarian cancer and other cancers with similar DNA repair issues.

Who is the study for?

This trial is for adults with advanced solid tumors and a specific gene mutation called tPALB2. They should have tried all standard treatments or be unsuitable for them, and not have other cancers needing systemic treatment. Participants can't join if they've had certain recent treatments, previous PARP inhibitors, ovarian/prostate cancer, high blood pressure uncontrolled by medication, or specific genetic mutations.

What is being tested?

The study tests the effectiveness and safety of Niraparib in patients with various types of advanced cancers like breast, lung, colorectal etc., who carry the PALB2 mutation. It's aimed at those whose disease has progressed despite standard therapies or who cannot tolerate such treatments.

What are the potential side effects?

Niraparib may cause side effects including nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, heart palpitations, insomnia and constipation. Some people might experience changes in liver function tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed PALB2 gene mutation.

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My cancer is advanced or has spread and was confirmed by a lab test.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a BRCA1 or BRCA2 gene mutation.

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I have been treated with PARP inhibitors before.

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My cancer returned after treatment with platinum-based therapy.

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I have brain-related complications from cancer.

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I have another cancer that needs treatment.

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I have ovarian or prostate cancer.

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My blood pressure is high even with medication.

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My genetic test shows uncertain changes in the PALB2 gene, but no harmful mutations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR) - Independent Central Review (ICR)

Secondary study objectives

Clinical Benefit Rate (CBR) - Investigator and ICR

Duration of Response (DOR) - Independent Central Review (ICR)

Duration of Response (DOR) - Investigator

+7 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347

74%

Fatigue

52%

Nausea

39%

Constipation

39%

Anorexia

30%

Anemia

30%

Alkaline phosphatase increased

26%

Weight loss

22%

Abdominal pain

22%

Dizziness

22%

Insomnia

22%

Dyspnea

17%

Platelet count decreased

17%

Headache

17%

Mucositis oral

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Cough

Dehydration

Urinary tract infection

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Upper respiratory infection

Hoarseness

Hypotension

Hot flashes

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Hyperglycemia

Neutrophil count decreased

Tremor

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Bruising

Esophageal ulcer

Hyperkalemia

Peripheral sensory neuropathy

Leukocytosis

White blood cell decreased

Postnasal drip

Skin tear

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 MutationsExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung cancer include targeted therapies and immunotherapies. Targeted therapies, such as EGFR and ALK inhibitors, block specific proteins that promote cancer cell growth, making them highly effective for patients with these mutations. Immunotherapies, like PD-1 inhibitors, boost the immune system's ability to attack cancer cells. While PARP inhibitors like niraparib are primarily used in cancers with DNA repair deficiencies, they represent a growing area of interest for personalized cancer treatment. These therapies are crucial as they provide more tailored and potentially more effective treatment options with fewer side effects compared to traditional chemotherapy.