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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 5
Awards & highlights
Study 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.Check my eligibility
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.See study design
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).
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I can be treated with cisplatin-based chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-Free Survival (DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray
Secondary outcome measures
DFS Within Selected Populations
Maximum Plasma Concentration (Cmax) of Atezolizumab
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
+5 moreSide 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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
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
~5250
Gemcitabine
2017
Completed Phase 3
~2070
Atezolizumab
2017
Completed Phase 3
~5860
Cisplatin
2013
Completed Phase 3
~1940
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
2,432 Previous Clinical Trials
1,088,606 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,323 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Why is Atezolizumab commonly given to patients?
"Atezolizumab is commonly used to treat patients with advance directives. This medication can also be effective at treating other conditions including locally advanced pancreatic adenocarcinoma and malignant neoplasms."
Answered by AI
When was Atezolizumab cleared by the FDA?
"Atezolizumab's safety is estimated to be a 3. This evaluation comes from the fact that this drug is in Phase 3 trials, signifying that not only does some data support its efficacy, but multiple rounds of testing have shown it to be safe."
Answered by AI
Are people still being enrolled in this experiment?
"This particular clinical study is not presently enrolling patients. The trial was first advertised on October 31st, 2015 and updated most recently on November 7th, 2022. There are 2095 other trials actively recruiting patients with lung cancer and 1657 Atezolizumab trials also admitting patients if you wish to explore other options."
Answered by AI
Is Atezolizumab a common ingredient in other medical research?
"Atezolizumab was first researched in 1997 at City of Hope Comprehensive Cancer Center. Out of the 2510 completed studies, 1657 are ongoing with many taking place in Summit, New jersey."
Answered by AI
Where are the patients being seen for this trial?
"At the moment, patients are being accepted at Overlook Medical Center; Medical Diagnostic Associates in Summit, New jersey, Va Greater Los Angeles Healthcare System in Sepulveda, California, and VA Puget Sound Health Care Sys in Seattle, Washington. Additionally, there are 61 other potential sites for recruitment."
Answered by AI
How many individuals have signed up to participate in this clinical trial?
"This trial is no longer looking for participants. The study was first posted on October 31st, 2015 and the most recent update occurred on November 7th, 2022. If you are interested in other studies, there are currently 2095 active clinical trials related to lung cancer and 1657 with Atezolizumab that need patients."
Answered by AI
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