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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
Adequate hematologic and end-organ function
Histological or cytological diagnosis of Stage IB-IIIA NSCLC
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 below
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My blood and organs are functioning well.
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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 had lung cancer surgery 4-12 weeks ago and have recovered.
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I can be treated with cisplatin-based chemotherapy.

Timeline

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

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 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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
2016
Completed Phase 3
~6040
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
2,426 Previous Clinical Trials
1,087,852 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
887,280 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02486718 — Phase 3
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02486718 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Atezolizumab, Best Supportive Care
Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT02486718 — Phase 3

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
Recent research and studies
~137 spots leftby Mar 2025