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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

Must not have

Non-squamous NSCLC histology with activating ALK and EGFR mutation

History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 96 months

Awards & highlights

Pivotal Trial

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.

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.

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.

Exclusion Criteria

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

Select...

My lung cancer is non-squamous with specific ALK and EGFR mutations.

Select...

I have a history of lung scarring or inflammation.

Select...

I have not had a severe infection in the last 4 weeks.

Select...

I have a significant history of heart disease.

Select...

My lung cancer is a mix of non-small cell and small cell types.

Select...

My lung cancer is a specific type called large cell neuroendocrine or sarcomatoid carcinoma.

Select...

I have previously been treated with specific immune therapies.

Select...

I have received treatment for lung cancer before.

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

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

Primary study objectives

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

Secondary study objectives

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

2-Year and 3-Year Investigator-Assessed EFS

2-Year and 3-Year OS

+13 more

Side effects data

From 2023 Phase 3 trial • 453 Patients • NCT03191786

22%

Decreased appetite

20%

Cough

19%

Fatigue

19%

Dyspnoea

17%

Anaemia

16%

Constipation

14%

Asthenia

13%

Diarrhoea

11%

Pneumonia

11%

Nausea

10%

Pyrexia

10%

Urinary tract infection

10%

Rash

Arthralgia

Hyponatraemia

Back pain

Hypertension

Vomiting

Oedema peripheral

Pruritus

Weight decreased

Hypothyroidism

Hypokalaemia

Haemoptysis

Insomnia

Blood creatinine increased

Headache

Dizziness

Pain in extremity

Pleural effusion

Pneumonitis

Death

Lower respiratory tract infection

Infective exacerbation of chronic obstructive airways disease

Chronic obstructive pulmonary disease

Hyperglycaemia

Femur fracture

Diabetic ketoacidosis

Atrial fibrillation

Bronchitis

Acute myocardial infarction

Immune-mediated hepatitis

Cardiac failure

Cellulitis

Sudden cardiac death

Fall

Pneumonia aspiration

Septic shock

Respiratory tract infection

Upper respiratory tract infection

Femoral neck fracture

Leukopenia

Neutropenia

Syncope

Acute kidney injury

Pneumothorax

Pulmonary embolism

Respiratory failure

Deep vein thrombosis

Neutrophil count decreased

White blood cell count decreased

Hypercalcaemia

Confusional state

100%

80%

60%

40%

20%

Study treatment Arm

Atezolizumab

Single Agent Chemotherapy (Vinorelbine or Gemcitabine)

Awards & Highlights

Pivotal Trial

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

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

~1950

Pemetrexed

2014

Completed Phase 3

~5550