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PARP Inhibitor

Atezolizumab + Talazoparib for Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Nagla Abdel Karim

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as: At least two (3-5 microns) (three slides preferred) unstained slides, or; One (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide. Participants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing

Participants must be >= 18 years of age at the time of Step 1 Screening Registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of maintenance randomization until death from any cause, with participants last known to be alive censored at the date of last contact, assessed up to 3 years from randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether atezolizumab, an immunotherapy drug, in combination with talazoparib, a PARP inhibitor, is more effective than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer.

Who is the study for?

This trial is for adults with extensive-stage small cell lung cancer (ES-SCLC) confirmed by biopsy, who have completed initial treatment without disease progression or severe immune-related side effects. They must not have mixed SCLC/NSCLC histology, active pneumonitis, uncontrolled diseases like diabetes or infections, and no prior immunotherapy for SCLC. Participants need adequate organ function and cannot be pregnant or breastfeeding.

What is being tested?

The study tests if atezolizumab combined with talazoparib improves outcomes in ES-SCLC patients with the SLFN11 biomarker compared to atezolizumab alone. Atezolizumab is an antibody that may boost the immune system's response to cancer; talazoparib inhibits PARP proteins involved in DNA repair in tumor cells.

What are the potential side effects?

Potential side effects include allergic reactions to medication components, liver issues, blood disorders such as low white cell count which can increase infection risk, fatigue from anemia due to low platelets, and possible kidney problems reflected by abnormal creatinine levels.

Eligibility Criteria

Inclusion Criteria

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

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I can provide the required tumor tissue samples for testing.

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I am 18 years old or older.

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I have not had a bone marrow or organ transplant.

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I've had 2 to 4 rounds of treatment with platinum/etoposide/atezolizumab.

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I've had a brain scan within the last 42 days and do not have untreated brain cancer.

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I can swallow pills without any issues.

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I haven't had any live vaccines in the last 28 days and won't during the study.

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I do not have severe kidney disease or other serious illnesses that limit my life expectancy or ability to participate in a study.

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I have no allergies to medications similar to atezolizumab or talazoparib.

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I do not have active tuberculosis.

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My tumor is SLFN11 positive according to SWOG SDMC.

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I had hepatitis C but have been treated and cured, or I am on treatment with an undetectable viral load.

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I have not had severe infections or been hospitalized for them in the last 14 days.

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I have been diagnosed with extensive stage small cell lung cancer.

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I have never had lung conditions like idiopathic pulmonary fibrosis or pneumonitis.

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I have been diagnosed with extensive stage small cell lung cancer without any mix of other lung cancer types.

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My diabetes is under control (HgA1C ≤ 7%).

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I am not taking, nor plan to take, certain medications that affect how drugs work in my body.

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I have not had immunotherapy for small cell lung cancer before starting treatment.

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I haven't taken high doses of steroids like prednisone (more than 10 mg daily) in the last week.

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I do not have any significant liver diseases like cirrhosis or fatty liver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of maintenance randomization until death from any cause, with participants last known to be alive censored at the date of last contact, assessed up to 3 years from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of maintenance randomization until death from any cause, with participants last known to be alive censored at the date of last contact, assessed up to 3 years from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of maintenance randomization until death from any cause, with participants last known to be alive censored at the date of last contact, assessed up to 3 years from randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival

Secondary study objectives

Overall survival

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (atezolizumab, talazoparib)Experimental Treatment6 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo MRI during screening. Patients undergo tumor biopsy while on study. Patients undergo CT scan and blood sample collection throughout the study.

Group II: Arm I (atezolizumab)Active Control5 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo MRI during screening. Patients undergo tumor biopsy while on study. Patients undergo CT scan and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

2021

Completed Phase 2

~2810

Atezolizumab

2016

Completed Phase 3

~5860