Atezolizumab for Small cell carcinoma of lung

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, AR
Small cell carcinoma of lung+2 More
Atezolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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. The Arm II therapy regimen of atezolizumab and talazoparib has been approved by the FDA for the treatment of Extensive Stage Small Cell Lung Carcinoma. This is a clinical trial in which all patients will receive the Arm II therapy, as there is no placebo group.

Eligible Conditions

  • Small cell carcinoma of lung

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 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

Month 18
Progression free survival
Year 3
Overall survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm I (atezolizumab)
1 of 2
Arm II (atezolizumab, talazoparib)
1 of 2
Active Control
Experimental Treatment

94 Total Participants · 2 Treatment Groups

Primary Treatment: Atezolizumab · No Placebo Group · Phase 2

Arm II (atezolizumab, talazoparib)Experimental Group · 2 Interventions: Atezolizumab, Talazoparib · Intervention Types: Drug, Drug
Arm I (atezolizumab)
Drug
ActiveComparator Group · 1 Intervention: Atezolizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Talazoparib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Closest Location: NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro · Jonesboro, AR
Photo of arkansas 1Photo of arkansas 2Photo of arkansas 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Small cell carcinoma of lung
0 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,930 Previous Clinical Trials
41,293,693 Total Patients Enrolled
Nagla Abdel KarimPrincipal InvestigatorSouthwest Oncology Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry.
Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration.
The slides must be stained.
One unstained slide plus one H&E stained slide.
You must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
The sponsor's identity is provided to ensure that the institutional review board has approved the study.
Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.