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Monoclonal Antibodies

Atezolizumab + Chemotherapy for Non-Small Cell 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

Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the AJCC/UICC staging system

Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 96 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that includes a combination of atezolizumab and platinum-based chemotherapy. The trial will compare the new treatment to placebo and best supportive care to see if it is more effective.

Who is the study for?

This trial is for people with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC). Participants must be able to undergo surgery, have not had prior lung cancer treatment, and should not have other cancers within the last 5 years. They need good heart and lung function, no serious infections recently, no history of certain autoimmune diseases or pneumonitis, and cannot be pregnant.Check my eligibility

What is being tested?

The study tests Atezolizumab (an anti-PD-L1 antibody) combined with chemotherapy before surgery compared to a placebo plus chemotherapy in patients with NSCLC. After surgery, participants will receive Atezolizumab or supportive care. The goal is to see if this improves outcomes.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs including lungs and intestines; infusion-related reactions; fatigue; blood disorders like anemia; increased risk of infections due to weakened immune defenses.

Eligibility Criteria

Inclusion Criteria

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

Select...

My lung cancer is confirmed and can be surgically removed. It's classified as Stage II, IIIA, or certain IIIB.

Select...

A thoracic surgeon has confirmed I can have surgery to remove all of my lung cancer.

Select...

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

Select...

My heart and lungs are strong enough for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 96 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 96 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 96 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Independent Review Facility (IRF)-Assessed Event Free Survival (EFS)

Secondary outcome measures

2-Year and 3-Year Independent Review Facility-Assessed EFS

2-Year and 3-Year Investigator-Assessed EFS

2-Year and 3-Year OS

+16 more

Side effects data

From 2023 Phase 3 trial • 453 Patients • NCT03191786

22%

Decreased appetite

20%

Cough

19%

Fatigue

18%

Dyspnoea

16%

Constipation

16%

Anaemia

14%

Asthenia

13%

Diarrhoea

11%

Pneumonia

11%

Nausea

10%

Pyrexia

10%

Rash

10%

Urinary tract infection

Arthralgia

Back pain

Hyponatraemia

Vomiting

Oedema peripheral

Pruritus

Hypertension

Weight decreased

Hypokalaemia

Haemoptysis

Hypothyroidism

Insomnia

Headache

Blood creatinine increased

Dizziness

Pain in extremity

Pleural effusion

Pneumonitis

Lower respiratory tract infection

Death

Infective exacerbation of chronic obstructive airways disease

Chronic obstructive pulmonary disease

Syncope

Immune-mediated hepatitis

Acute myocardial infarction

Leukopenia

Neutropenia

Diabetic ketoacidosis

Respiratory tract infection

Septic shock

Cardiac failure

Hyperglycaemia

Sudden cardiac death

Atrial fibrillation

Upper respiratory tract infection

Fall

Femoral neck fracture

Femur fracture

Acute kidney injury

White blood cell count decreased

Cellulitis

Bronchitis

Pneumonia aspiration

Pneumothorax

Pulmonary embolism

Deep vein thrombosis

Hypercalcaemia

Confusional state

100%

80%

60%

40%

20%

Study treatment Arm

Atezolizumab

Single Agent Chemotherapy (Vinorelbine or Gemcitabine)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A: Atezolizumab + platinum-based chemotherapyExperimental Treatment6 Interventions

Neoadjuvant treatment will consist of 4 cycles; atezolizumab + platinum-based chemotherapy Platinum-based chemotherapy may include: carboplatin + pemetrexed carboplatin + nab-paclitaxel cisplatin + pemetrexed cisplatin + gemcitabine Post-operative adjuvant treatment will consist of 16-cycles of atezolizumab

Group II: Arm B: Placebo + platinum-based chemotherapyPlacebo Group6 Interventions

Neoadjuvant treatment will consist of 4 cycles; placebo + platinum-based chemotherapy Platinum-based chemotherapy may include: carboplatin + pemetrexed carboplatin + nab-paclitaxel cisplatin + pemetrexed cisplatin + gemcitabine Participants will receive best supportive care and monitoring after surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab-paclitaxel

2014

Completed Phase 3

~2030

Pemetrexed

2014

Completed Phase 3

~5250

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

2016

Completed Phase 3

~4630

Carboplatin

2014

Completed Phase 3

~6670

Gemcitabine

2017

Completed Phase 3

~2070

Cisplatin

2013

Completed Phase 3

~1940

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,601 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,049 Total Patients Enrolled

Media Library

Atezolizumab (MPDL3280A) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03456063 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Arm A: Atezolizumab + platinum-based chemotherapy, Arm B: Placebo + platinum-based chemotherapy

Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab (MPDL3280A) Highlights & Side Effects. Trial Name: NCT03456063 — Phase 3

Atezolizumab (MPDL3280A) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03456063 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Atezolizumab (MPDL3280A) received FDA approval as an antibody against PD-L1?

"Atezolizumab (MPDL3280A) is an antibody that was designed to target PD-L1. In our opinion at Power, it rates a 3 on the safety scale because Phase III trials have been conducted which support both its efficacy and safety."

Answered by AI

What is Atezolizumab (MPDL3280A) used to treat most effectively?

"Atezolizumab, an antibody that targets the protein PD-L1, can be used to treat several different types of cancer including metastatic ureter urothelial carcinoma, lymphoma, and non-small cell lung cancer."

Answered by AI

Can patients still join this research initiative?

"Unfortunately, this study is no longer recruiting patients. The trial was initially posted on April 24th, 2018 and saw its last update on November 10th, 2022. There are presently 2037 trials for Atezolizumab (MPDL3280A) enrolling patients and 1392 clinical trials actively recruiting participants with carcinoma, non-small-cell lung cancer."

Answered by AI

How many people are included in this research project?

"This clinical trial is not looking for new participants at the moment. The study was originally posted on April 24th, 2018 and updated November 10th, 2020. If you're interested in other studies, there are 1392 trials recruiting patients with carcinoma, non-small-cell lung and 2037 that involve Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody."

Answered by AI

Are there many places in the city where this clinical trial is taking place?

"To make the enrollment process as smooth as possible for patients, the trial is running at 17 locations. These sites are situated in Detroit, Orange and Los Angeles with 14 other centres."

Answered by AI

What other research has been done using Atezolizumab (MPDL3280A), an antibody that targets PD-L1?

"Atezolizumab (MPDL3280A), an antibody created to target PD-L1, was originally studied in 1997 at City of Hope Comprehensive Cancer Center. As of now, there have been a total of 3036 completed trials with 2037 active studies. Many of these trials are based in Detroit, Michigan."

Answered by AI

Recent research and studies

European Journal of Cardio-Thoracic SurgeryJournal

Outcomes of Surgical Resection After Neoadjuvant Chemoimmunotherapy in Locally Advanced Stage IIIA Non-small-cell Lung Cancer

Romero Román, Alejandra, Jose Luis Campo-Cañaveral de la Cruz, Iván Macía, Ignacio Escobar Campuzano, Santiago Figueroa Almánzar, María Delgado Roel, Carlos Gálvez Muñoz, et al.. 2021. “Outcomes of Surgical Resection After Neoadjuvant Chemoimmunotherapy in Locally Advanced Stage IIIA Non-small-cell Lung Cancer”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezab007.

clinicaltrials.govStudy

A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)

2018. "A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03456063.

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