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Checkpoint Inhibitor

Atezolizumab After Chemotherapy for Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Histological or cytological diagnosis of Stage IB-IIIA NSCLC

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment

Prior treatment with CD137 agonists or immune checkpoint blockade therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 5

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new cancer treatment against the current best treatment, to see if the new treatment is more effective in preventing the cancer from returning.

Who is the study for?

This trial is for adults who've had surgery to remove non-small cell lung cancer (NSCLC) and are now ready for chemotherapy. They should be in good physical condition with a performance status of 0 or 1, have no recent infections, not pregnant, and without a history of severe allergies to drugs used in the study. People with certain other health issues or treatments within the last five years can't join.

What is being tested?

The trial tests if Atezolizumab given over 16 cycles improves survival compared to just supportive care after surgery and chemo in NSCLC patients. It's an open-label study where participants are randomly chosen to get either the drug or supportive care after their initial chemo treatment.

What are the potential side effects?

Atezolizumab may cause immune-related reactions like inflammation in organs, infusion reactions similar to allergic responses, fatigue, possible liver enzyme changes leading to hepatitis symptoms, skin rash or itching, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is at an early to mid-stage (Stage IB-IIIA).

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I am fully active or restricted in physically strenuous activity but can do light work.

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I can be treated with cisplatin-based chemotherapy.

Exclusion Criteria

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

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I have had hormone therapy or radiation for cancer within the last 5 years.

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I have previously been treated with CD137 agonists or immune checkpoint inhibitors.

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I have active hepatitis B or C.

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I have active tuberculosis.

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I have a history of lung scarring or inflammation not caused by infections.

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I am not allergic to any part of the planned chemotherapy or mannitol.

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My cancer is of the squamous cell type.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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I have had a bone marrow or organ transplant in the past.

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I have not had chemotherapy in the last 5 years.

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I have not had signs of infection in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 5 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease-Free Survival (DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray

Secondary study objectives

DFS Within Selected Populations

Percentage of Participants Who are Disease-Free at Year 3, Assessed Using CT/MRI/X-Ray

Cognitive Therapy

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AtezolizumabExperimental Treatment6 Interventions

Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.

Group II: Best Supportive CareActive Control5 Interventions

Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemetrexed

2014

Completed Phase 3

~5550

Gemcitabine

2017

Completed Phase 3

~1920