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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
STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible
Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible
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

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 below
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I have been diagnosed with extensive stage small cell lung cancer.
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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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I have completed the first 3 days of my initial cancer treatment including platinum and etoposide, with or without atezolizumab.
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I may be getting or have had brain or chest radiation.
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I have not had immunotherapy for small cell lung cancer before starting treatment.
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I am 18 years old or older.
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I can provide the required tumor tissue samples for testing.
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I can safely follow the study's requirements despite my decision-making challenges.
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My tumor is SLFN11 positive according to SWOG SDMC.
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My disease was checked with a CT or PET scan after my first treatment.
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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 am registered for the next phase of the trial before starting atezolizumab.
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I've had 2 to 4 rounds of treatment with platinum/etoposide/atezolizumab.
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I haven't had radiation or brain protection treatment in the last 14 days.
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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 haven't had severe side effects from previous immune therapy, except for stable conditions treated with replacement therapy.
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My heart is healthy enough for the trial, even with my history of heart issues or treatments.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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I have chronic hepatitis B but it's under control with treatment.
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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 HIV, am on effective treatment, and my viral load is undetectable.
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I can swallow pills without any issues.
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My diabetes is under control (HgA1C ≤ 7%).
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I do not have any significant liver diseases like cirrhosis or fatty liver.
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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 never had lung conditions like idiopathic pulmonary fibrosis or pneumonitis.
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I do not have active tuberculosis.
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I have not had a bone marrow or organ transplant.
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I have no allergies to medications similar to atezolizumab or talazoparib.
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I don't have another cancer that could affect this treatment's safety or results.
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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 haven't had any live vaccines in the last 28 days and won't during the study.
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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 agree to have my specimens collected and shared for research.
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I can safely follow the study's requirements despite my decision-making challenges.

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
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

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 • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Atezolizumab
2016
Completed Phase 3
~6040
Biopsy
2014
Completed Phase 4
~1160
Biospecimen Collection
2004
Completed Phase 1
~1850
Computed Tomography
2017
Completed Phase 2
~2710
Talazoparib
2021
Completed Phase 2
~2750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,576 Previous Clinical Trials
41,224,095 Total Patients Enrolled
Nagla Abdel KarimPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04334941 — Phase 2
Small Cell Lung Cancer Research Study Groups: Arm I (atezolizumab), Arm II (atezolizumab, talazoparib)
Small Cell Lung Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT04334941 — Phase 2
Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04334941 — Phase 2

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+

What questions have other patients asked about this trial?

How long do the screening visits take?
PatientReceived no prior treatments

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
~31 spots leftby Nov 2025