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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
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 belowSelect...
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:Select...
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.
Select...
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.
Select...
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
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 • NCT0200822736%
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
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Pneumonia
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
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
Atezolizumab
2017
Completed Phase 3
~5850
Cisplatin
2013
Completed Phase 3
~2360
Vinorelbine
2013
Completed Phase 4
~2190
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,444 Previous Clinical Trials
1,091,842 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
891,136 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have had hormone therapy or radiation for cancer within the last 5 years.I have previously been treated with CD137 agonists or immune checkpoint inhibitors.I have active hepatitis B or C.You are allergic to medications made from Chinese hamster ovary cells or any part of the atezolizumab medication.My lung cancer is at an early to mid-stage (Stage IB-IIIA).You have trouble hearing.You have a history of autoimmune disease.You have tested positive for HIV.I am not allergic to any part of the planned chemotherapy or mannitol.I do not have any health conditions that would make it unsafe for me to take a new drug.Your tumor has been tested for a protein called PD-L1 using a specific test in other studies.My cancer is of the squamous cell type.I have taken antibiotics by mouth or IV in the last 14 days.I haven't taken steroids or immunosuppressants in the last 14 days.I have had a bone marrow or organ transplant in the past.I had lung cancer surgery 4-12 weeks ago and have recovered.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I have not had serious heart problems in the last 3 months.I have a history of lung scarring or inflammation not caused by infections.My blood and organs are functioning well.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had any cancer other than NSCLC in the last 5 years, except for very low-risk types.I have active tuberculosis.If you are not past menopause or have had surgery to prevent pregnancy, you need to have a negative pregnancy test within 14 days before starting cisplatin-based chemotherapy.Women who are not past menopause or surgically unable to have children must have a negative pregnancy test within 14 days before starting the treatment.I can understand and follow the study's procedures.I can be treated with cisplatin-based chemotherapy.You have had serious allergic reactions to certain types of medications.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have not had chemotherapy in the last 5 years.I have not had signs of infection in the last 14 days.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab
- Group 2: Best Supportive Care
Awards:
This trial has 2 awards, including:- 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.
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