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Monoclonal Antibodies

Triple Therapy for Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Led By Jonathan W Goldman

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Male participants must use a condom when having sex with a pregnant woman or a woman of childbearing potential

Eastern Cooperative Oncology Group (ECOG) performance status of =< 1

Must not have

Progressive or symptomatic brain metastases, leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults with advanced solid tumors or extensive-stage small cell lung cancer who've responded to first-line platinum chemotherapy. They must be in good physical condition, not pregnant, willing to use contraception, and have no serious health issues or recent cancer treatments. Certain blood counts and organ functions are required.

What is being tested?

The study tests the combination of temozolomide (a chemo drug), niraparib (a PARP inhibitor that blocks DNA repair in cancer cells), and atezolizumab (an immunotherapy). It aims to find the best dose and see if this mix is more effective for patients with certain advanced cancers.

What are the potential side effects?

Possible side effects include fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, liver function changes, kidney function changes, allergic reactions to drugs used in treatment. Specific side effects will vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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I will use a condom with partners who are pregnant or can become pregnant.

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I am fully active or can carry out light work.

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My cancer type is approved for treatment with atezolizumab by the FDA.

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My kidney and liver tests are within normal limits.

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My cancer is advanced and cannot be cured with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or its coverings and is getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months 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 (Phase II)

Secondary study objectives

Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.0

Objective response rate

Overall survival

Other study objectives

Quality of life per Functional Assessment of Cancer Therapy - Lung questionnaire (FACT-L)

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 A (temozolomide, niraparib, atezolizumab)Experimental Treatment5 Interventions

Patients receive temozolomide PO QD on days 1-5 and niraparib PO QD on days 1-28. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (atezolizumab)Active Control3 Interventions

Patients receive standard of care atezolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

Atezolizumab

2016