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Temozolomide + Atezolizumab for Small Cell Lung Cancer

Phase 2

Recruiting

Led By Dwight H Owen

Research Sponsored by Dwight Owen

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically-documented diagnosis of extensive stage small cell lung cancer and progression or recurrence after platinum-based chemotherapy with immunotherapy

Maximum of 2 prior lines of systemic therapy allowed in the setting of metastatic disease

Must not have

Prior or concurrent malignancy with potential to interfere with the safety or efficacy assessment of the investigational regimen

Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from initiation of investigational therapy until the criteria for disease progression is met as defined by recist1.1 or death as a result of any cause, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effects of temozolomide and atezolizumab as second line treatment for patients with small cell lung cancer.

Who is the study for?

This trial is for adults with small cell lung cancer that has spread or returned after initial treatment. Participants must be able to take oral meds, have measurable disease, and a good performance status. They should not have had certain treatments recently and must agree to use contraception.

What is being tested?

The study tests temozolomide (a chemotherapy drug) combined with atezolizumab (an immunotherapy antibody) as second or third line treatments in patients whose cancer has metastasized or recurred. The goal is to see if this combo can extend survival times.

What are the potential side effects?

Possible side effects include typical chemotherapy-related issues like nausea, fatigue, hair loss, and increased risk of infection. Atezolizumab may cause immune system reactions leading to inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

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

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My small cell lung cancer has returned or worsened after treatment with platinum-based chemotherapy and immunotherapy.

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I have had no more than 2 treatments for my cancer after it spread.

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I am 18 years old or older.

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I can swallow and keep down pills.

Exclusion Criteria

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

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I do not have another cancer that could affect the trial's safety or results.

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I am currently on medication for a serious infection.

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I haven't had cancer treatments like chemotherapy or radiation in the last 2 weeks.

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I have previously been treated with temozolomide.

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I have not received a live vaccine in the last 4 weeks.

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I have high calcium levels in my blood that are causing symptoms.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

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I have had cancer spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initiation of investigational therapy until the criteria for disease progression is met as defined by recist1.1 or death as a result of any cause, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from initiation of investigational therapy until the criteria for disease progression is met as defined by recist1.1 or death as a result of any cause, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of investigational therapy until the criteria for disease progression is met as defined by recist1.1 or death as a result of any cause, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Investigator-assessed objective response rate (ORR)

Secondary study objectives

Intracranial PFS

Overall survival

Progression free survival (PFS)

+1 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

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

Group I: Cohort II (atezolizumab, temozolomide)Experimental Treatment2 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive temozolomide PO QD on days 1-14 of cycle 1 and days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Cohort I (atezolizumab, temozolomide)Experimental Treatment2 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Atezolizumab

2016

Completed Phase 3

~5860