What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy agents like etoposide, cisplatin, and topotecan, as well as newer agents like PARP inhibitors (e.g., Talazoparib) and temozolomide. Known side effects of these treatments include hematologic toxicities such as anemia, thrombocytopenia, and neutropenia. Non-hematologic side effects can include nausea, fatigue, and neuropathy. Specifically, Talazoparib may cause mild to moderate non-hematologic adverse events like nausea and anorexia, while temozolomide can lead to myelosuppression and gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC), primarily focusing on chemotherapy and immunotherapy. Chemotherapy regimens such as etoposide combined with cisplatin or carboplatin have been standard first-line treatments. For relapsed SCLC, topotecan has been approved as a second-line treatment. Recently, immune checkpoint inhibitors like nivolumab and atezolizumab have also received FDA approval for SCLC. While specific approvals for PARP inhibitors like Talazoparib in SCLC are not detailed, the combination of chemotherapy and emerging targeted therapies continues to be a focus of clinical research.

What other types of research exist?

Promising novel alternatives for Small Cell Lung Cancer (SCLC) patients include immunotherapy agents such as pembrolizumab and nivolumab, which have shown efficacy in treating SCLC. Additionally, novel targeted therapies and combination regimens involving immune checkpoint inhibitors and other agents are being actively investigated in clinical trials.

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PARP Inhibitor

Talazoparib + Temozolomide for Small Cell Lung Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for Small Cell Lung Cancer (SCLC) include PARP inhibitors and chemotherapy. PARP inhibitors, such as Talazoparib, prevent cancer cells from repairing their DNA, leading to cell death. Chemotherapy agents, like Temozolomide, work by damaging the DNA of cancer cells or inhibiting their ability to divide and grow. These mechanisms are vital for SCLC patients because this type of cancer is highly aggressive and spreads quickly. By targeting the cancer cells' repair and proliferation capabilities, these treatments can effectively combat the rapid progression of SCLC.

Phase 2

Recruiting

Led By Jonathan Goldman, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of =< 1

Cytologically or histologically confirmed small cell lung cancer (SCLC) with extensive-stage disease

Must not have

Prior treatment with a PARP inhibitor (not including iniparib) or temozolomide

Diagnosis of myelodysplastic syndrome (MDS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how effective talazoparib and temozolomide are for treating patients with extensive-stage small cell lung cancer that has come back after initial chemotherapy. Talazoparib stops cancer cells from repairing their DNA, while temozolomide kills or stops the growth of these cells. The combination may work better than either drug alone.

Who is the study for?

This trial is for adults with extensive-stage small cell lung cancer that has returned after initial chemotherapy. Participants must be able to swallow pills, not have used PARP inhibitors or temozolomide before, and agree to contraception. They should not have other cancers within the last 2 years (with some exceptions) or conditions affecting study participation.

What is being tested?

The effectiveness of talazoparib combined with low-dose temozolomide is being tested in participants with relapsed or refractory extensive-stage small cell lung cancer. Talazoparib may prevent tumor cells from repairing DNA, while temozolomide aims to stop their growth.

What are the potential side effects?

Potential side effects include blood disorders like anemia and neutropenia, fatigue, nausea, vomiting, hair loss (alopecia), constipation or diarrhea. There might also be risks related to DNA repair inhibition such as secondary cancers.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My lung cancer is confirmed to be extensive-stage small cell type.

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I can provide a tissue sample for testing.

Exclusion Criteria

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

Select...

I have been treated with a PARP inhibitor or temozolomide before.

Select...

I have been diagnosed with myelodysplastic syndrome.

Select...

I have undergone more than one round of chemotherapy.

Select...

I have a stomach or intestine condition that affects how my body absorbs food.

Select...

I am not using and do not plan to use certain medications that could affect my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIS)T 1.1

Secondary study objectives

Duration of response (CR or PR) per RECIST 1.1

Overall survival

PFS assessed by RECIST 1.1

+3 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777

100%

Fatigue

100%

Headache

67%

Platelet count decreased

67%

Hyperglycemia

67%

Anemia

67%

Back pain

33%

Alopecia

33%

Weight loss

33%

Nausea

33%

Sinus tachycardia

33%

Investigations - Other, BUN DECREASED

33%

Urinary incontinence

33%

Peripheral motor neuropathy

33%

Hyponatremia

33%

Hypoglycemia

33%

Hypothyroidism

33%

Neutrophil count decreased

33%

White blood cell decreased

33%

Scoliosis

33%

Hypokalemia

33%

Insomnia

33%

Creatinine increased

33%

Alanine aminotransferase increased

33%

Peripheral sensory neuropathy

33%

Fever

33%

Diarrhea

33%

Hypermagnesemia

33%

Lymphocyte count decreased

33%

Hypophosphatemia

33%

Gastroesophageal reflux disease

33%

Skin ulceration

33%

Nervous system disorders - Other, PARALYSIS

33%

Muscle weakness lower limb

33%

Cough

33%

Non-cardiac chest pain

33%

Skin infection

33%

Nystagmus

33%

Arthralgia

33%

Gait disturbance

33%

Edema limbs

33%

Hypertension

33%

Investigations - Other, ALT DECREASED

33%

Chills

33%

Investigations - Other, AST DECREASED

33%

Nervous system disorders - Other, HYPOTONIC

33%

Aspartate aminotransferase increased

33%

Blurred vision

33%

Constipation

33%

Pain in extremity

33%

Alkaline phosphatase increased

33%

Neuralgia

33%

Skin and subcutaneous tissue disorders - Other, LEFT LOWER LEG ERYTHEMA

33%

Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day

400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day

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: Treatment (temozolomide, talazoparib)Experimental Treatment2 Interventions

Participants receive temozolomide PO on days 1-5 and talazoparib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

2021

Completed Phase 2

~2810

Temozolomide

2010

Completed Phase 3

~1880

0 / 8Eligibility 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

The most common treatments for Small Cell Lung Cancer (SCLC) include PARP inhibitors and chemotherapy. PARP inhibitors, such as Talazoparib, prevent cancer cells from repairing their DNA, leading to cell death. Chemotherapy agents, like Temozolomide, work by damaging the DNA of cancer cells or inhibiting their ability to divide and grow. These mechanisms are vital for SCLC patients because this type of cancer is highly aggressive and spreads quickly. By targeting the cancer cells' repair and proliferation capabilities, these treatments can effectively combat the rapid progression of SCLC.