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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Secondary outcome measures
Overall survival
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Talazoparib
2021
Completed Phase 2
~2770
Atezolizumab
2017
Completed Phase 3
~5860
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,059 Total Patients Enrolled
Nagla Abdel KarimPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine levels or clearance, is within the normal range.I am 18 years old or older.I have not had immunotherapy for small cell lung cancer before starting treatment.I can provide the required tumor tissue samples for testing.I have chronic hepatitis B but it's under control with treatment.I have not had a bone marrow or organ transplant.I can take care of myself and am up and about more than 50% of my waking hours.You need to provide at least three microscope slides containing tissue samples.I've had 2 to 4 rounds of treatment with platinum/etoposide/atezolizumab.I've had a brain scan within the last 42 days and do not have untreated brain cancer.I can swallow pills without any issues.I don't have another cancer that could affect this treatment's safety or results.I haven't had any live vaccines in the last 28 days and won't during the study.Your liver enzyme levels are not more than three times the normal limit.I do not have severe kidney disease or other serious illnesses that limit my life expectancy or ability to participate in a study.I have completed the first 3 days of my initial cancer treatment including platinum and etoposide, with or without atezolizumab.I haven't had severe side effects from previous immune therapy, except for stable conditions treated with replacement therapy.I can safely follow the study's requirements despite my decision-making challenges.I have HIV, am on effective treatment, and my viral load is undetectable.You must allow the M.D. Anderson Cancer Center to test your tissue for a specific marker called SLFN11. A review of your tissue will be done to make sure there is enough material for the test. If there isn't enough tissue, more can be submitted if it's done before starting maintenance therapy.I have no allergies to medications similar to atezolizumab or talazoparib.I do not have active tuberculosis.I agree to have my specimens collected and shared for research.My tumor is SLFN11 positive according to SWOG SDMC.I had hepatitis C but have been treated and cured, or I am on treatment with an undetectable viral load.My disease was checked with a CT or PET scan after my first treatment.I have completed at least 3 days of my first cycle of treatment with platinum, etoposide, and possibly atezolizumab.I have not had severe infections or been hospitalized for them in the last 14 days.I have been diagnosed with extensive stage small cell lung cancer.I have never had lung conditions like idiopathic pulmonary fibrosis or pneumonitis.I may be getting or have had brain or chest radiation.Your doctor thinks your disease has not gotten worse after starting treatment.I have been diagnosed with extensive stage small cell lung cancer without any mix of other lung cancer types.Your white blood cell count is at least 3,000 cells per microliter within the last 28 days before starting the next step of the study.My heart is healthy enough for the trial, even with my history of heart issues or treatments.I am registered for the next phase of the trial before starting atezolizumab.I haven't had radiation or brain protection treatment in the last 14 days.Your white blood cell count is at least 1.5 x 10^3/mL within the past 28 days.You have not previously received any experimental treatment for your small cell lung cancer.My diabetes is under control (HgA1C ≤ 7%).Your platelet count is greater than or equal to 100,000 per microliter within the last 28 days before the second part of the study.Your total bilirubin level must be within the normal range set by the hospital within 28 days before the second part of the trial.I am not taking, nor plan to take, certain medications that affect how drugs work in my body.I have not had immunotherapy for small cell lung cancer before starting treatment.I haven't taken high doses of steroids like prednisone (more than 10 mg daily) in the last week.I do not have any significant liver diseases like cirrhosis or fatty liver.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (atezolizumab)
- Group 2: Arm II (atezolizumab, talazoparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant count for this experimental procedure?
"This is no longer an active trial, as the study was initially posted on June 15th 2020 and last updated September 29th 2022. If you are looking for other medical studies, there are currently 301 trials recruiting participants with small cell carcinoma of lung and 401 clinical trials utilizing Atezolizumab that have open enrollment opportunities."
Answered by AI
What indications has Atezolizumab been found to ameliorate?
"Atezolizumab can be utilized as a pharmacotherapeutic approach to combat malignant neoplasms, including small cell lung cancer (sclc)."
Answered by AI
How widespread is the deployment of this investigation?
"This research project is being administered at Abbott-Northwestern Hospital in Minneapolis, MN as well as Capital Region Southwest Campus in Jefferson City, MO and Dayton Physicians LLC-Wayne in Greenville, OH amongst a total of 100 different trial sites."
Answered by AI
Have any similar trials been conducted previously?
"Atezolizumab was initially researched in 2008, with the pioneering study being sponsored by Hoffmann-La Roche. Following this initial expriment involving 720 patients, Atezolizumab progressed to Phase 2 drug approval. Currently, there are 401 active research projects for Atezolizumab transpiring across 1826 cities and 75 countries worldwide."
Answered by AI
Has Atezolizumab previously been explored in other research efforts?
"Atezolizumab was first investigated at SCRI Tennessee Oncology Chattanooga in 2008, leading to 103 successful trials. At present, 401 ongoing studies are conducted across the USA - a great many of which originate from Minneapolis."
Answered by AI
What deleterious effects might Atezolizumab pose to individuals?
"The safety of Atezolizumab has been assessed and scored at a 2, as the Phase 2 trial results suggest some assurance in terms of its security but no efficacy data."
Answered by AI
Are applications still being accepted for this research experiment?
"Sadly, no more patients are being solicited for this medical research. Initially posted on June 15th 2020 and last edited September 29th 2022, the trial is now closed. However, individuals looking for similar studies may find it useful to know that there are 301 trials recruiting small cell carcinoma of lung patients and 401 clinical trials seeking participants with Atezolizumab treatments."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
Louisiana
How old are they?
65+
18 - 65
What site did they apply to?
University of California Davis Comprehensive Cancer Center
Northshore Oncology Associates-Covington
Mercy Hospital Washington
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I am stable on Tecentric but am always thinking about clinical trials as a way to help me live longer.
PatientReceived 1 prior treatment
I was diagnosed on October 13,2017 with extensive small call in my right upper lung around my superior vena cava . I'm currently stable. There's always that question in the back of your mind wondering when it's going to eat its ugly head again.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long do the screening visits take?
PatientReceived no prior treatments
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