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Checkpoint Inhibitor

Atezolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Nasser Hanna, MD

Research Sponsored by Nasser Hanna

Eligibility Criteria Checklist

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

Must have

Squamous or non-squamous NSCLC histology. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology".

Patients must have undergone complete surgical resection of their stage I (tumors >= 4cm), IIA, IIB, and select stage III [any T1-3 N1-2 and T4N0-2] NSCLC according to the AJCC 8th edition with negative margins (R0).

Must not have

Prior chemotherapy, radiation therapy, or immunotherapy is NOT allowed for the treatment of this lung cancer.

Prior chemotherapy and/or radiation therapy is permissible for the treatment of other previous cancers, but must have been completed at least 3 months prior to registration for this trial.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding the immunotherapy drug atezolizumab to standard chemotherapy after surgery can help people with early-stage lung cancer live longer without their disease coming back.

Who is the study for?

This trial is for adults who've had surgery to remove certain stages of non-small cell lung cancer and have detectable ctDNA, indicating a risk of recurrence. They must be in good health with proper organ function, not pregnant or breastfeeding, willing to use contraception, and haven't received prior treatments for this cancer. People with other active cancers, severe allergies to atezolizumab or its components, autoimmune diseases, infections like HIV or hepatitis B/C are excluded.

What is being tested?

The study tests if adding the drug Atezolizumab to standard chemotherapy after surgery can prevent cancer from coming back in patients with specific stages of lung cancer who have signs of residual disease (ctDNA). It will check if clearing ctDNA from blood correlates with longer periods without disease and overall survival.

What are the potential side effects?

Atezolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems (hepatitis), skin reactions, hormonal gland issues (like thyroid disorders), infusion reactions; fatigue; potential worsening of pre-existing autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is either squamous or non-squamous.

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My lung cancer was surgically removed with clear margins.

Exclusion Criteria

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

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I have not had chemotherapy, radiation, or immunotherapy for this lung cancer.

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I finished treatments for a previous cancer more than 3 months ago.

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I have or had an autoimmune disease like lupus, rheumatoid arthritis, or multiple sclerosis.

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My blood thinner medication dose is not stable.

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I have been treated with specific immune therapy targeting cancer.

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I have an active tuberculosis infection.

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My cancer does not have EGFR mutations or ALK rearrangements.

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I haven't had major heart problems or strokes in the last 3 months.

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I do not have lung disease that causes symptoms or could affect drug side effect management.

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I have or had Hepatitis B or currently have Hepatitis C.

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I have had or currently have lung inflammation treated with steroids.

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I haven't had a severe infection or been hospitalized for one in the last 4 weeks.

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I have had a transplant of stem cells or an organ from another person.

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I do not have any other active cancers.

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

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My cancer does not have small or large cell neuroendocrine features.

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I am on high-dose steroids or other drugs that weaken my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of patients with undetectable ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors ≥ 4cm), IIA, IIB, and select stage III [any T1-3 N1-2 and T4N0-2]

Secondary study objectives

1 year Disease Free Survival (DFS) in all patients

1 year Disease Free Survival (DFS) in patients with detectable ctDNA after 1 year of adjuvant therapy on study

1 year Disease Free Survival (DFS) in patients with no detectable ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab who had detectable ctDNA after surgery.

+5 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: SC: Squamous cell tumorsExperimental Treatment3 Interventions

Atezolizumab 1200mg, Docetaxel 60-75 mg/m\^2, Cisplatin 60-75 mg/m\^2

Group II: NSC: Non-squamous cell tumorsExperimental Treatment3 Interventions

Atezolizumab 1200mg, Pemetrexed 500 mg/m\^2, Cisplatin 60-75 mg/m\^2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Pemetrexed

2014

Completed Phase 3

~5550

Docetaxel

1995

Completed Phase 4

~6550

Cisplatin

2013

Completed Phase 3

~3120

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nasser HannaLead Sponsor

3 Previous Clinical Trials

50 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,564 Previous Clinical Trials

570,619 Total Patients Enrolled

Nasser Hanna, MD5.013 ReviewsPrincipal Investigator - Indiana University

Big Ten Cancer Research Consortium

6 Previous Clinical Trials

133 Total Patients Enrolled

5Patient Review

Dr. Hannah is truly the best of the best. They are so informative and take the time to explain your condition, treatment options, and what to expect. I would recommend them to anyone going through a cancer situation.