Your session is about to expire
← Back to Search
PD-L1 Inhibitor
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody for Small Cell Lung Cancer (IMpower133 Trial)
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 2 years
Awards & highlights
IMpower133 Trial Summary
This study is evaluating whether a drug called atezolizumab can improve the survival of people with small cell lung cancer.
IMpower133 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year, 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Overall Survival (OS) in the Global Population
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Secondary outcome measures
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in the Global Population
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
+8 moreSide effects data
From 2023 Phase 3 trial • 453 Patients • NCT0319178622%
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
9%
Arthralgia
8%
Back pain
8%
Hyponatraemia
8%
Vomiting
8%
Oedema peripheral
8%
Pruritus
7%
Hypertension
7%
Weight decreased
6%
Hypokalaemia
6%
Haemoptysis
6%
Hypothyroidism
6%
Insomnia
5%
Headache
5%
Blood creatinine increased
5%
Dizziness
4%
Pain in extremity
3%
Pleural effusion
3%
Pneumonitis
2%
Lower respiratory tract infection
2%
Death
2%
Infective exacerbation of chronic obstructive airways disease
2%
Chronic obstructive pulmonary disease
1%
Syncope
1%
Immune-mediated hepatitis
1%
Acute myocardial infarction
1%
Leukopenia
1%
Neutropenia
1%
Diabetic ketoacidosis
1%
Respiratory tract infection
1%
Septic shock
1%
Cardiac failure
1%
Hyperglycaemia
1%
Sudden cardiac death
1%
Atrial fibrillation
1%
Upper respiratory tract infection
1%
Fall
1%
Femoral neck fracture
1%
Femur fracture
1%
Acute kidney injury
1%
White blood cell count decreased
1%
Cellulitis
1%
Bronchitis
1%
Pneumonia aspiration
1%
Pneumothorax
1%
Pulmonary embolism
1%
Deep vein thrombosis
1%
Hypercalcaemia
1%
Confusional state
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)
IMpower133 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Atezolizumab + Carboplatin + EtoposideExperimental Treatment3 Interventions
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Group II: Placebo + Carboplatin + EtoposideActive Control3 Interventions
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
2016
Completed Phase 3
~4630
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,088,907 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,229 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger