Quality-of-Life Assessment for Stage IVB Lung Cancer AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stage IVB Lung Cancer AJCC v8+11 More
Quality-of-Life Assessment - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the best dose of temozolomide to give with niraparib and atezolizumab to treat patients with advanced solid tumors and extensive-stage small cell lung cancer.

Eligible Conditions
  • Stage IVB Lung Cancer AJCC v8
  • Malignant Neoplasms
  • Small cell carcinoma of lung
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Advance Directives

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 36 months

At 28 days
Recommended phase II dose of niraparib and temozolomide combination (Phase Ib)
Month 36
Progression-free survival (Phase II)
Month 36
Overall survival
Up to 36 months
Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.0
Objective response rate
Quality of life per Functional Assessment of Cancer Therapy - Lung questionnaire (FACT-L)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm B (atezolizumab)
1 of 2
Arm A (temozolomide, niraparib, atezolizumab)
1 of 2

Active Control

Experimental Treatment

74 Total Participants · 2 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 1 & 2

Arm A (temozolomide, niraparib, atezolizumab)Experimental Group · 5 Interventions: Atezolizumab, Niraparib, Questionnaire Administration, Quality-of-Life Assessment, Temozolomide · Intervention Types: Biological, Drug, Other, Other, Drug
Arm B (atezolizumab)ActiveComparator Group · 3 Interventions: Atezolizumab, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Biological, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Niraparib
FDA approved
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months

Who is running the clinical trial?

Tesaro, Inc.Industry Sponsor
55 Previous Clinical Trials
10,309 Total Patients Enrolled
Translational Research in OncologyOTHER
19 Previous Clinical Trials
6,765 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
338 Previous Clinical Trials
21,595 Total Patients Enrolled
2 Trials studying Stage IVB Lung Cancer AJCC v8
50 Patients Enrolled for Stage IVB Lung Cancer AJCC v8
Jonathan W GoldmanPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Stage IVB Lung Cancer AJCC v8
26 Patients Enrolled for Stage IVB Lung Cancer AJCC v8

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: November 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.