Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Carcinoma, Non-Small-Cell Lung+1 More
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Carcinoma, Non-Small-Cell Lung
  • Non Small Cell Lung

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: Up to approximately 96 months

At time of surgery
Major Pathological Response (MPR)
Pathological Complete Response (pCR)
Month 96
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Month 96
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab
Day 84
Objective Response (OR)
Month 96
2-Year and 3-Year Independent Review Facility-Assessed EFS
2-Year and 3-Year Investigator-Assessed EFS
2-Year and 3-Year OS
Change from baseline in HRQoL scores
Disease-Free Survival (DFS)
Independent Review Facility (IRF)-Assessed Event Free Survival (EFS)
Investigator-Assessed EFS
Length of Surgical Delays
Number and Severity of Surgical Related Adverse Events
Number of Operative and Post-Operative Complications
Number of Surgical Delays
Overall Survival (OS)
Percentage of Participants With Adverse Events (AEs)
Reasons for Surgical Cancellations

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Arm B (Atezo+Bev+CP)
48%ALOPECIA
38%NAUSEA
35%FATIGUE
33%ARTHRALGIA
32%DIARRHOEA
31%CONSTIPATION
30%ANAEMIA
30%DECREASED APPETITE
26%HYPERTENSION
23%NEUROPATHY PERIPHERAL
22%COUGH
21%ASTHENIA
20%PROTEINURIA
18%NEUTROPENIA
18%MYALGIA
18%HEADACHE
18%RASH
18%VOMITING
17%PYREXIA
17%PERIPHERAL SENSORY NEUROPATHY
17%EPISTAXIS
17%DYSPNOEA
15%PLATELET COUNT DECREASED
15%BACK PAIN
15%PRURITUS
14%HYPOMAGNESAEMIA
14%STOMATITIS
13%HYPOTHYROIDISM
13%WEIGHT DECREASED
13%PAIN IN EXTREMITY
13%PARAESTHESIA
13%THROMBOCYTOPENIA
12%NEUTROPHIL COUNT DECREASED
11%INSOMNIA
10%MUCOSAL INFLAMMATION
9%ABDOMINAL PAIN
9%OEDEMA PERIPHERAL
9%UPPER RESPIRATORY TRACT INFECTION
9%URINARY TRACT INFECTION
9%HYPOKALAEMIA
9%CHEST PAIN
8%ALANINE AMINOTRANSFERASE INCREASED
8%DEHYDRATION
8%ASPARTATE AMINOTRANSFERASE INCREASED
8%ANXIETY
7%FEBRILE NEUTROPENIA
7%PNEUMONIA
7%MALAISE
7%NASOPHARYNGITIS
7%PAIN
7%BRONCHITIS
7%WHITE BLOOD CELL COUNT DECREASED
7%DIZZINESS
7%DYSPHONIA
7%DRY SKIN
6%HYPONATRAEMIA
6%BONE PAIN
6%DYSGEUSIA
6%OROPHARYNGEAL PAIN
6%DEPRESSION
5%DRY MOUTH
5%HAEMOPTYSIS
5%MUSCLE SPASMS
5%GASTROOESOPHAGEAL REFLUX DISEASE
4%LEUKOPENIA
2%COLITIS
2%PNEUMONITIS
1%CARDIAC FAILURE
1%ADRENAL INSUFFICIENCY
1%GASTRITIS
1%GENERAL PHYSICAL HEALTH DETERIORATION
1%DEATH
1%HEPATITIS
1%LARGE INTESTINE INFECTION
1%PNEUMONIA BACTERIAL
1%SEPTIC SHOCK
1%SEPSIS
1%RESPIRATORY TRACT INFECTION
1%FALL
1%VIRAL INFECTION
1%VASCULAR DEVICE INFECTION
1%HIP FRACTURE
1%PROCEDURAL COMPLICATION
1%CEREBRAL ISCHAEMIA
1%CEREBROVASCULAR ACCIDENT
1%SEIZURE
1%TRANSIENT ISCHAEMIC ATTACK
1%CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1%ACUTE KIDNEY INJURY
1%NEPHROLITHIASIS
1%PULMONARY HAEMORRHAGE
1%AORTIC DISSECTION
1%HYPOTENSION
1%THROMBOSIS
1%ACUTE MYOCARDIAL INFARCTION
1%ATRIAL FIBRILLATION
1%CHOLANGITIS
1%PRERENAL FAILURE
1%RENAL FAILURE
1%HYPOXIA
1%PULMONARY EMBOLISM
1%DEEP VEIN THROMBOSIS
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02366143) in the Arm B (Atezo+Bev+CP) ARM group. Side effects include: ALOPECIA with 48%, NAUSEA with 38%, FATIGUE with 35%, ARTHRALGIA with 33%, DIARRHOEA with 32%.

Trial Design

2 Treatment Groups

Arm A: Atezolizumab + platinum-based chemotherapy
1 of 2
Arm B: Placebo + platinum-based chemotherapy
1 of 2

Experimental Treatment

Non-Treatment Group

453 Total Participants · 2 Treatment Groups

Primary Treatment: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody · Has Placebo Group · Phase 3

Arm A: Atezolizumab + platinum-based chemotherapyExperimental Group · 6 Interventions: Nab-paclitaxel, Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin, Gemcitabine, Cisplatin, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Arm B: Placebo + platinum-based chemotherapyPlaceboComparator Group · 6 Interventions: Nab-paclitaxel, Carboplatin, Gemcitabine, Cisplatin, Placebo Comparator, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Atezolizumab
FDA approved
Carboplatin
FDA approved
Gemcitabine
FDA approved
Cisplatin
FDA approved
Pemetrexed
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 96 months

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,352 Previous Clinical Trials
1,093,599 Total Patients Enrolled
139 Trials studying Carcinoma, Non-Small-Cell Lung
48,028 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
Clinical TrialsStudy DirectorHoffmann-La Roche
2,134 Previous Clinical Trials
901,093 Total Patients Enrolled
137 Trials studying Carcinoma, Non-Small-Cell Lung
52,309 Patients Enrolled for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC that is histologically or cytologically confirmed can be surgically resected
The thoracic surgeon examined the patient and found that they were eligible for an R0 resection with curative intent.
is mandatory Requirements for surgery include good pulmonary and heart function.
You must have a good performance status to join this study
The individual screened negative for active HBV and HCV.
was available from tumor specimens of all Patients All patients had tumors that could be adequatly sampled for PD-L1 IHC analysis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.