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Trial record 1 of 1 for:    NCT02763579
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A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) (IMpower133)

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ClinicalTrials.gov Identifier: NCT02763579
Recruitment Status : Active, not recruiting
First Posted : May 5, 2016
Results First Posted : June 13, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Small Cell Lung Carcinoma
Interventions Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Drug: Carboplatin
Drug: Etoposide
Drug: Placebo
Enrollment 403
Recruitment Details  
Pre-assignment Details Participants in this study included: extensive-stage small cell lung cancer (ES-SCLC) with no prior systemic treatment for ES-SCLC.
Arm/Group Title Atezolizumab + Carboplatin + Etoposide Placebo + Carboplatin + Etoposide
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 201 202
Completed 0 0
Not Completed 201 202
Reason Not Completed
Death             101             132
Lost to Follow-up             3             1
Withdrawal by Subject             18             9
Physician Decision             2             0
On-going in study             77             60
Arm/Group Title Atezolizumab + Carboplatin + Etoposide Placebo + Carboplatin + Etoposide Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 201 202 403
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 202 participants 403 participants
63.8  (8.8) 63.6  (9.0) 63.7  (8.9)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 202 participants 403 participants
Female
72
  35.8%
70
  34.7%
142
  35.2%
Male
129
  64.2%
132
  65.3%
261
  64.8%
[1]
Measure Description: As reported from Electronic Case Report Form (eCRF).
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 202 participants 403 participants
American Indian or Alaska Native
0
   0.0%
1
   0.5%
1
   0.2%
Asian
33
  16.4%
36
  17.8%
69
  17.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.5%
2
   1.0%
3
   0.7%
White
163
  81.1%
159
  78.7%
322
  79.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   2.0%
4
   2.0%
8
   2.0%
1.Primary Outcome
Title Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).
Time Frame Baseline until PD or death, whichever occurs first (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atezolizumab + Carboplatin + Etoposide Placebo + Carboplatin + Etoposide
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 201 202
Median (95% Confidence Interval)
Unit of Measure: Months
5.2
(4.4 to 5.6)
4.3
(4.2 to 4.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab + Carboplatin + Etoposide, Placebo + Carboplatin + Etoposide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0170
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified Hazard Ratio
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.62 to 0.96
Estimation Comments [Not Specified]
2.Primary Outcome
Title Duration of Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Baseline until death from any cause (up to approximately 23 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atezolizumab + Carboplatin + Etoposide Placebo + Carboplatin + Etoposide
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 201 202
Median (95% Confidence Interval)
Unit of Measure: Months
12.3
(10.8 to 15.9)
10.3
(9.3 to 11.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atezolizumab + Carboplatin + Etoposide, Placebo + Carboplatin + Etoposide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0069
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified Hazard Ratio
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.54 to 0.91
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1
Hide Description [Not Specified]
Time Frame Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 46 months)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
Hide Description [Not Specified]
Time Frame First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 46 months)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 1 Year
Hide Description [Not Specified]
Time Frame 6 months, 1 year (up to approximately 46 months)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Percentage of Participants Alive at 1 Year and 2 Years
Hide Description [Not Specified]
Time Frame 1 year, 2 years (up to approximately 46 months)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) Score
Hide Description [Not Specified]
Time Frame Baseline until deterioration per symptom subscale (up to approximately 46 months)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title TTD Per EORTC QLQ Lung Cancer Module (LC13) Score
Hide Description [Not Specified]
Time Frame Baseline until deterioration per symptom subscale (up to approximately 46 months)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame Baseline until up to 90 days after end of treatment (up to approximately 46 months)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Percentage of Participants With Anti-Therapeutic Antibodies (ATAs)
Hide Description [Not Specified]
Time Frame Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 46 months) and 120 days after last dose (up to approximately 46 months overall)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Hide Description Atezolizumab infusion duration is 60 minutes for the first infusion and 30 minutes for subsequent infusions.
Time Frame Predose (0 H) and postdose (0.5 H) on D1 of C1; predose (0 H) on D1 of C2, 3, 4, 8, 16, and Q8C thereafter (cycle = 21 days) until treatment discontinuation (up to 46 months) and 120 days after last dose (up to approximately 46 months overall)
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Hide Description Atezolizumab infusion duration is 60 minutes for the first infusion and 30 minutes for subsequent infusions.
Time Frame Predose (0 H) on D1 of C1, 2, 3, 4, 8, 16, and Q8C thereafter (cycle = 21 days) until treatment discontinuation (up to 46 months) and 120 days after last dose (up to approximately 46 months overall)
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Plasma Concentration of Carboplatin
Hide Description [Not Specified]
Time Frame Predose (0 H) and 5-10 minutes before end/1 H after end of carboplatin infusion (infusion duration = 1 H) on D1 of C1 and C3 (cycle = 21 days)(up to approximately 46 months)
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Plasma Concentration of Etoposide
Hide Description [Not Specified]
Time Frame Predose (0 H) and 5-10 minutes before end/1 H and 4H after end of etoposide infusion (infusion duration = 1 H) on D1 of C1 and C3 (cycle = 21 days)(up to approximately 46 months)
Outcome Measure Data Not Reported
Time Frame From the first study drug administration to the data cutoff date: 24 April 2018 (up to 23 months).
Adverse Event Reporting Description Adverse Events reporting is for the Safety Evaluable Participants. Safety Evaluable Participants is defined as patients who received any amount of any component of study treatment.
 
Arm/Group Title Atezolizumab + Carboplatin + Etoposide Placebo + Carboplatin + Etoposide
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Atezolizumab + Carboplatin + Etoposide Placebo + Carboplatin + Etoposide
Affected / at Risk (%) Affected / at Risk (%)
Total   103/198 (52.02%)      130/196 (66.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Atezolizumab + Carboplatin + Etoposide Placebo + Carboplatin + Etoposide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/198 (37.37%)      68/196 (34.69%)    
Blood and lymphatic system disorders     
ANAEMIA   3/198 (1.52%)  4 2/196 (1.02%)  2
DISSEMINATED INTRAVASCULAR COAGULATION   0/198 (0.00%)  0 1/196 (0.51%)  1
FEBRILE NEUTROPENIA   5/198 (2.53%)  5 9/196 (4.59%)  9
LEUKOCYTOSIS   0/198 (0.00%)  0 1/196 (0.51%)  1
LEUKOPENIA   2/198 (1.01%)  2 1/196 (0.51%)  1
NEUTROPENIA   7/198 (3.54%)  7 8/196 (4.08%)  8
PANCYTOPENIA   0/198 (0.00%)  0 4/196 (2.04%)  4
THROMBOCYTOPENIA   5/198 (2.53%)  5 4/196 (2.04%)  4
Cardiac disorders     
ATRIAL FIBRILLATION   1/198 (0.51%)  1 2/196 (1.02%)  3
ATRIOVENTRICULAR BLOCK COMPLETE   1/198 (0.51%)  1 0/196 (0.00%)  0
CARDIAC FAILURE   0/198 (0.00%)  0 1/196 (0.51%)  1
CARDIAC TAMPONADE   1/198 (0.51%)  1 0/196 (0.00%)  0
CARDIOPULMONARY FAILURE   0/198 (0.00%)  0 1/196 (0.51%)  1
PERICARDIAL EFFUSION   1/198 (0.51%)  1 1/196 (0.51%)  1
SUPRAVENTRICULAR TACHYCARDIA   0/198 (0.00%)  0 1/196 (0.51%)  1
Endocrine disorders     
AUTOIMMUNE THYROIDITIS   2/198 (1.01%)  2 0/196 (0.00%)  0
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION   0/198 (0.00%)  0 1/196 (0.51%)  1
Gastrointestinal disorders     
ABDOMINAL ADHESIONS   1/198 (0.51%)  2 0/196 (0.00%)  0
ABDOMINAL PAIN   1/198 (0.51%)  1 0/196 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION   1/198 (0.51%)  2 0/196 (0.00%)  0
NAUSEA   1/198 (0.51%)  1 0/196 (0.00%)  0
LIP OEDEMA   1/198 (0.51%)  1 0/196 (0.00%)  0
INTESTINAL OBSTRUCTION   1/198 (0.51%)  1 0/196 (0.00%)  0
ILEUS   1/198 (0.51%)  1 0/196 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE   0/198 (0.00%)  0 1/196 (0.51%)  1
GASTRITIS   1/198 (0.51%)  1 0/196 (0.00%)  0
FAECES DISCOLOURED   0/198 (0.00%)  0 1/196 (0.51%)  1
GASTRIC ULCER PERFORATION   0/198 (0.00%)  0 1/196 (0.51%)  1
DIVERTICULAR PERFORATION   1/198 (0.51%)  1 0/196 (0.00%)  0
DIARRHOEA   3/198 (1.52%)  3 1/196 (0.51%)  1
COLITIS   2/198 (1.01%)  2 0/196 (0.00%)  0
PANCREATITIS   0/198 (0.00%)  0 1/196 (0.51%)  3
PANCREATITIS ACUTE   1/198 (0.51%)  1 0/196 (0.00%)  0
PROCTITIS   1/198 (0.51%)  1 0/196 (0.00%)  0
AUTOIMMUNE COLITIS   1/198 (0.51%)  1 0/196 (0.00%)  0
VOMITING   3/198 (1.52%)  3 3/196 (1.53%)  3
General disorders     
ASTHENIA   2/198 (1.01%)  2 1/196 (0.51%)  1
CHEST PAIN   0/74 (0.00%)  0 1/68 (1.47%)  1
DEATH   1/198 (0.51%)  1 0/196 (0.00%)  0
FATIGUE   3/198 (1.52%)  3 0/196 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION   2/198 (1.01%)  2 1/196 (0.51%)  1
NON−CARDIAC CHEST PAIN   0/198 (0.00%)  0 1/196 (0.51%)  1
PYREXIA   2/198 (1.01%)  2 0/196 (0.00%)  0
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME   0/198 (0.00%)  0 1/196 (0.51%)  1
Hepatobiliary disorders     
CHOLANGITIS   1/198 (0.51%)  1 0/196 (0.00%)  0
JAUNDICE   1/198 (0.51%)  2 0/196 (0.00%)  0
Infections and infestations     
BRONCHITIS   2/198 (1.01%)  2 0/196 (0.00%)  0
CLOSTRIDIUM DIFFICILE COLITIS   1/198 (0.51%)  1 0/196 (0.00%)  0
CLOSTRIDIUM DIFFICILE INFECTION   0/198 (0.00%)  0 1/196 (0.51%)  1
CYTOMEGALOVIRUS INFECTION   1/198 (0.51%)  1 0/196 (0.00%)  0
LOWER RESPIRATORY TRACT INFECTION   2/198 (1.01%)  2 0/196 (0.00%)  0
LUNG ABSCESS   0/198 (0.00%)  0 1/196 (0.51%)  1
LUNG INFECTION   0/198 (0.00%)  0 3/196 (1.53%)  3
NEUTROPENIC SEPSIS   0/198 (0.00%)  0 1/196 (0.51%)  1
PNEUMONIA   9/198 (4.55%)  12 7/196 (3.57%)  8
PULMONARY SEPSIS   0/198 (0.00%)  0 1/196 (0.51%)  1
PYOPNEUMOTHORAX   0/198 (0.00%)  0 1/196 (0.51%)  1
RESPIRATORY TRACT INFECTION   1/198 (0.51%)  1 1/196 (0.51%)  1
SEPSIS   0/198 (0.00%)  0 1/196 (0.51%)  1
SEPTIC SHOCK   0/198 (0.00%)  0 1/196 (0.51%)  1
UPPER RESPIRATORY TRACT INFECTION   0/198 (0.00%)  0 1/196 (0.51%)  1
URINARY TRACT INFECTION   2/198 (1.01%)  2 2/196 (1.02%)  2
Injury, poisoning and procedural complications     
FEMUR FRACTURE   1/198 (0.51%)  1 1/196 (0.51%)  1
HEAD INJURY   1/198 (0.51%)  1 0/196 (0.00%)  0
INFUSION RELATED REACTION   1/198 (0.51%)  1 2/196 (1.02%)  2
RADIATION OESOPHAGITIS   0/198 (0.00%)  0 1/196 (0.51%)  1
THORACIC VERTEBRAL FRACTURE   0/198 (0.00%)  0 1/196 (0.51%)  1
Investigations     
ALANINE AMINOTRANSFERASE INCREASED   1/198 (0.51%)  1 1/196 (0.51%)  1
ASPARTATE AMINOTRANSFERASE INCREASED   1/198 (0.51%)  1 1/196 (0.51%)  1
BLOOD ALKALINE PHOSPHATASE INCREASED   1/198 (0.51%)  1 0/196 (0.00%)  0
BLOOD CREATININE INCREASED   1/198 (0.51%)  2 0/196 (0.00%)  0
LIVER FUNCTION TEST INCREASED   1/198 (0.51%)  1 0/196 (0.00%)  0
NEUTROPHIL COUNT DECREASED   0/198 (0.00%)  0 1/196 (0.51%)  1
PLATELET COUNT DECREASED   0/198 (0.00%)  0 2/196 (1.02%)  2
TRANSAMINASES INCREASED   1/198 (0.51%)  1 0/196 (0.00%)  0
WHITE BLOOD CELL COUNT DECREASED   0/198 (0.00%)  0 1/196 (0.51%)  1
Metabolism and nutrition disorders     
DEHYDRATION   1/198 (0.51%)  1 0/196 (0.00%)  0
HYPERGLYCAEMIA   2/198 (1.01%)  2 0/196 (0.00%)  0
HYPOKALAEMIA   0/198 (0.00%)  0 1/196 (0.51%)  1
HYPOMAGNESAEMIA   0/198 (0.00%)  0 1/196 (0.51%)  1
HYPONATRAEMIA   1/198 (0.51%)  1 4/196 (2.04%)  4
Musculoskeletal and connective tissue disorders     
ARTHRALGIA   1/198 (0.51%)  1 0/196 (0.00%)  0
PAIN IN EXTREMITY   1/198 (0.51%)  1 0/196 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
METASTATIC NEOPLASM   1/198 (0.51%)  1 0/196 (0.00%)  0
TUMOUR PAIN   0/198 (0.00%)  0 1/196 (0.51%)  1
Nervous system disorders     
CEREBROVASCULAR ACCIDENT   0/198 (0.00%)  0 1/196 (0.51%)  1
GUILLAIN−BARRE SYNDROME   1/198 (0.51%)  1 0/196 (0.00%)  0
NEUROPATHY PERIPHERAL   1/198 (0.51%)  1 0/196 (0.00%)  0
SOMNOLENCE   1/198 (0.51%)  1 0/196 (0.00%)  0
SPINAL CORD OEDEMA   0/198 (0.00%)  0 1/196 (0.51%)  1
SYNCOPE   3/198 (1.52%)  3 0/196 (0.00%)  0
TRANSIENT ISCHAEMIC ATTACK   1/198 (0.51%)  1 0/196 (0.00%)  0
TRIGEMINAL NEURALGIA   1/198 (0.51%)  1 0/196 (0.00%)  0
Psychiatric disorders     
ALCOHOL ABUSE   0/198 (0.00%)  0 1/196 (0.51%)  1
DEPRESSION   1/198 (0.51%)  1 0/196 (0.00%)  0
Renal and urinary disorders     
ACUTE KIDNEY INJURY   2/198 (1.01%)  2 0/196 (0.00%)  0
TUBULOINTERSTITIAL NEPHRITIS   1/198 (0.51%)  1 0/196 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY FAILURE   0/198 (0.00%)  0 2/196 (1.02%)  2
BRONCHIAL OBSTRUCTION   1/198 (0.51%)  1 0/196 (0.00%)  0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE   2/198 (1.01%)  2 2/196 (1.02%)  3
DYSPNOEA   1/198 (0.51%)  1 2/196 (1.02%)  2
HAEMOPTYSIS   2/198 (1.01%)  2 1/196 (0.51%)  1
HYPERCAPNIA   0/198 (0.00%)  0 1/196 (0.51%)  1
PLEURAL EFFUSION   2/198 (1.01%)  2 1/196 (0.51%)  1
PNEUMONITIS   1/198 (0.51%)  1 2/196 (1.02%)  2
PNEUMOTHORAX   0/198 (0.00%)  0 1/196 (0.51%)  1
PULMONARY EMBOLISM   0/198 (0.00%)  0 2/196 (1.02%)  2
PULMONARY OEDEMA   1/198 (0.51%)  1 0/196 (0.00%)  0
RESPIRATORY FAILURE   1/198 (0.51%)  1 0/196 (0.00%)  0
Skin and subcutaneous tissue disorders     
RASH   0/198 (0.00%)  0 1/196 (0.51%)  1
SKIN TOXICITY   1/198 (0.51%)  1 0/196 (0.00%)  0
Vascular disorders     
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE   1/198 (0.51%)  1 0/196 (0.00%)  0
PERIPHERAL ARTERY OCCLUSION   0/198 (0.00%)  0 1/196 (0.51%)  1
SUPERIOR VENA CAVA SYNDROME   1/198 (0.51%)  1 0/196 (0.00%)  0
THROMBOPHLEBITIS   1/198 (0.51%)  1 0/196 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atezolizumab + Carboplatin + Etoposide Placebo + Carboplatin + Etoposide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   190/198 (95.96%)      186/196 (94.90%)    
Blood and lymphatic system disorders     
ANAEMIA   84/198 (42.42%)  95 67/196 (34.18%)  83
LEUKOPENIA   24/198 (12.12%)  42 19/196 (9.69%)  32
NEUTROPENIA   71/198 (35.86%)  122 66/196 (33.67%)  105
THROMBOCYTOPENIA   31/198 (15.66%)  45 29/196 (14.80%)  44
Endocrine disorders     
HYPERTHYROIDISM   11/198 (5.56%)  11 5/196 (2.55%)  5
HYPOTHYROIDISM   20/198 (10.10%)  20 1/196 (0.51%)  1
Gastrointestinal disorders     
CONSTIPATION   51/198 (25.76%)  61 58/196 (29.59%)  69
DIARRHOEA   32/198 (16.16%)  42 30/196 (15.31%)  46
NAUSEA   74/198 (37.37%)  99 64/196 (32.65%)  89
STOMATITIS   11/198 (5.56%)  11 9/196 (4.59%)  9
VOMITING   38/198 (19.19%)  47 31/196 (15.82%)  45
General disorders     
ASTHENIA   23/198 (11.62%)  27 19/196 (9.69%)  25
CHEST PAIN   16/198 (8.08%)  19 12/196 (6.12%)  12
FATIGUE   51/198 (25.76%)  65 49/196 (25.00%)  61
OEDEMA PERIPHERAL   13/198 (6.57%)  14 7/196 (3.57%)  8
PYREXIA   18/198 (9.09%)  29 16/196 (8.16%)  18
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION   14/198 (7.07%)  16 16/196 (8.16%)  19
URINARY TRACT INFECTION   12/198 (6.06%)  16 5/196 (2.55%)  5
Injury, poisoning and procedural complications     
INFUSION RELATED REACTION   10/198 (5.05%)  13 8/196 (4.08%)  9
Investigations     
NEUTROPHIL COUNT DECREASED   37/198 (18.69%)  74 45/196 (22.96%)  80
PLATELET COUNT DECREASED   25/198 (12.63%)  36 28/196 (14.29%)  39
WEIGHT DECREASED   20/198 (10.10%)  20 10/196 (5.10%)  11
WHITE BLOOD CELL COUNT DECREASED   18/198 (9.09%)  35 24/196 (12.24%)  43
Metabolism and nutrition disorders     
DECREASED APPETITE   54/198 (27.27%)  62 36/196 (18.37%)  39
HYPOKALAEMIA   8/198 (4.04%)  8 17/196 (8.67%)  18
HYPOMAGNESAEMIA   12/198 (6.06%)  17 9/196 (4.59%)  9
HYPONATRAEMIA   10/198 (5.05%)  10 12/196 (6.12%)  14
Musculoskeletal and connective tissue disorders     
ARTHRALGIA   18/198 (9.09%)  20 13/196 (6.63%)  16
BACK PAIN   17/198 (8.59%)  17 19/196 (9.69%)  21
MUSCULOSKELETAL PAIN   12/198 (6.06%)  14 11/196 (5.61%)  13
PAIN IN EXTREMITY   13/198 (6.57%)  13 6/196 (3.06%)  7
Nervous system disorders     
DIZZINESS   19/198 (9.60%)  22 11/196 (5.61%)  14
HEADACHE   24/198 (12.12%)  28 23/196 (11.73%)  25
Psychiatric disorders     
INSOMNIA   15/198 (7.58%)  18 13/196 (6.63%)  13
Respiratory, thoracic and mediastinal disorders     
COUGH   18/198 (9.09%)  22 25/196 (12.76%)  29
DYSPNOEA   19/198 (9.60%)  22 16/196 (8.16%)  17
HAEMOPTYSIS   14/198 (7.07%)  20 10/196 (5.10%)  10
OROPHARYNGEAL PAIN   12/198 (6.06%)  15 5/196 (2.55%)  6
PRODUCTIVE COUGH   10/198 (5.05%)  10 9/196 (4.59%)  14
Skin and subcutaneous tissue disorders     
ALOPECIA   73/198 (36.87%)  75 68/196 (34.69%)  71
PRURITUS   12/198 (6.06%)  12 9/196 (4.59%)  10
RASH   14/198 (7.07%)  21 11/196 (5.61%)  13
RASH MACULO−PAPULAR   10/198 (5.05%)  10 2/196 (1.02%)  3
Vascular disorders     
HYPERTENSION   15/198 (7.58%)  20 6/196 (3.06%)  8
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02763579     History of Changes
Other Study ID Numbers: GO30081
2015-004861-97 ( EudraCT Number )
First Submitted: May 4, 2016
First Posted: May 5, 2016
Results First Submitted: April 19, 2019
Results First Posted: June 13, 2019
Last Update Posted: June 19, 2019