Trial Outcomes & Findings for Sorafenib/Erlotinib Versus Erlotinib Alone in Previously Treated Advanced Non-Small-Cell Lung Cancer (NSCLC) (NCT NCT00600015)
NCT ID: NCT00600015
Last Updated: 2022-03-10
Results Overview
Overall response rate (ORR) is defined as the percentage of patients who have a partial or complete response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0). Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters)
COMPLETED
PHASE2
166 participants
18 months
2022-03-10
Participant Flow
Participant milestones
| Measure |
Combination Therapy
sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
|
Placebo
Placebo twice daily orally plus erlotinib (150 mg orally daily)
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
55
|
|
Overall Study
COMPLETED
|
51
|
20
|
|
Overall Study
NOT COMPLETED
|
60
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sorafenib/Erlotinib Versus Erlotinib Alone in Previously Treated Advanced Non-Small-Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=111 Participants
sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
|
Placebo
n=55 Participants
Placebo twice daily orally plus erlotinib (150 mg orally daily)
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=93 Participants
|
65 years
n=4 Participants
|
65 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=93 Participants
|
55 participants
n=4 Participants
|
166 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 18 monthsOverall response rate (ORR) is defined as the percentage of patients who have a partial or complete response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0). Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters)
Outcome measures
| Measure |
Combination Therapy
n=111 Participants
sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
|
Placebo
n=55 Participants
Placebo twice daily orally plus erlotinib (150 mg orally daily)
|
|---|---|---|
|
Overall Objective Response Rate (ORR)
|
8.1 percentage of participants
Interval 3.77 to 14.83
|
10.9 percentage of participants
Interval 4.11 to 22.25
|
PRIMARY outcome
Timeframe: 18 monthsProgression-free survival is defined as the time from the first day of treatment until the day tumor progression was documented. Response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Outcome measures
| Measure |
Combination Therapy
n=111 Participants
sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
|
Placebo
n=55 Participants
Placebo twice daily orally plus erlotinib (150 mg orally daily)
|
|---|---|---|
|
Progression Free Survival (PFS)
|
3.38 Months
Interval 2.3 to 3.81
|
1.94 Months
Interval 1.77 to 3.65
|
PRIMARY outcome
Timeframe: 18 monthsDisease Control Rate (DCR) is defined as the percentage of patients who have a partial/complete/stable response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0). Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters) Stable Response: Neither sufficient shrinkage to qualify for partial response, nor sufficient increase to qualify for progressive disease (taking as reference the smallest sum of diameters since the treatment started).
Outcome measures
| Measure |
Combination Therapy
n=111 Participants
sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
|
Placebo
n=55 Participants
Placebo twice daily orally plus erlotinib (150 mg orally daily)
|
|---|---|---|
|
Disease Control Rate (DCR)
|
54 percentage of participants
Interval 44.0 to 64.0
|
38 percentage of participants
Interval 25.0 to 52.0
|
SECONDARY outcome
Timeframe: 18 monthsDuration of response is defined as the time from when objective response is realized until time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Objective Response = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Combination Therapy
n=111 Participants
sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
|
Placebo
n=55 Participants
Placebo twice daily orally plus erlotinib (150 mg orally daily)
|
|---|---|---|
|
Duration of Response
|
4.6430 months
Standard Error 1.0048
|
5.2234 months
Standard Error 0.4571
|
SECONDARY outcome
Timeframe: 6 monthsProgression free survival is defined as the time from the first day of treatment until the day tumor progression was documented. Response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions (1). Percentage of participants who were progression free at 6 month from the start of treatment is reported here.
Outcome measures
| Measure |
Combination Therapy
n=111 Participants
sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
|
Placebo
n=55 Participants
Placebo twice daily orally plus erlotinib (150 mg orally daily)
|
|---|---|---|
|
6-month PFS
|
29 percentage of participants
|
22 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsOS is defined as the time from the first treatment until date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to last date the participant was known to be alive.
Outcome measures
| Measure |
Combination Therapy
n=111 Participants
sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily)
|
Placebo
n=55 Participants
Placebo twice daily orally plus erlotinib (150 mg orally daily)
|
|---|---|---|
|
Overall Survival (OS)
|
7.62 Months
Interval 5.35 to 10.54
|
7.23 Months
Interval 4.04 to 12.58
|
Adverse Events
All Study Participants
Serious adverse events
| Measure |
All Study Participants
n=166 participants at risk
Reported SAEs and AEs for all study participants -
Combination Therapy: Erlotinib + Sorafenib Placebo: Erlotinib + Placebo
|
|---|---|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.60%
1/166 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
2.4%
4/166 • Number of events 4
|
|
Cardiac disorders
Supraventricular Arrhythmia - Atrial Fibrillation
|
0.60%
1/166 • Number of events 1
|
|
Cardiac disorders
Supraventricular Arrhythmia - Atrial Tachycardia
|
1.2%
2/166 • Number of events 2
|
|
Cardiac disorders
Supraventricular Arrhythmia
|
0.60%
1/166 • Number of events 1
|
|
Cardiac disorders
Pericardial Effusion
|
0.60%
1/166 • Number of events 2
|
|
Cardiac disorders
Cardiac Troponin I
|
0.60%
1/166 • Number of events 1
|
|
Nervous system disorders
Chest Pain
|
0.60%
1/166 • Number of events 1
|
|
General disorders
Death
|
1.2%
2/166 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
1.2%
2/166 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
4/166 • Number of events 4
|
|
Gastrointestinal disorders
Obstruction - Small Bowel
|
0.60%
1/166 • Number of events 2
|
|
Gastrointestinal disorders
Fistula - Esophagus
|
0.60%
1/166 • Number of events 1
|
|
Gastrointestinal disorders
Perforation - Small Bowel
|
0.60%
1/166 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
1.2%
2/166 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
0.60%
1/166 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.60%
1/166 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction - Esophagus
|
0.60%
1/166 • Number of events 1
|
|
Hepatobiliary disorders
Liver Dysfunction
|
0.60%
1/166 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.60%
1/166 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.4%
4/166 • Number of events 6
|
|
Infections and infestations
Sepsis
|
0.60%
1/166 • Number of events 1
|
|
Infections and infestations
Fungal Infection
|
0.60%
1/166 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.60%
1/166 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.60%
1/166 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
1.2%
2/166 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.2%
2/166 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
1.2%
2/166 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.60%
1/166 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Other
|
0.60%
1/166 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
|
10.8%
18/166 • Number of events 18
|
|
Nervous system disorders
Pain
|
5.4%
9/166 • Number of events 10
|
|
Nervous system disorders
Neurology - Other
|
0.60%
1/166 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.60%
1/166 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.60%
1/166 • Number of events 1
|
|
Nervous system disorders
Mental Status
|
0.60%
1/166 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.60%
1/166 • Number of events 1
|
|
Nervous system disorders
CNS Ischemia
|
0.60%
1/166 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
0.60%
1/166 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.4%
14/166 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
1.2%
2/166 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.60%
1/166 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.60%
1/166 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Airway Obstruction - COPD
|
1.2%
2/166 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.60%
1/166 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.60%
1/166 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
0.60%
1/166 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.60%
1/166 • Number of events 1
|
|
Vascular disorders
Thrombosis/Thrombis/Embolism
|
1.8%
3/166 • Number of events 3
|
Other adverse events
| Measure |
All Study Participants
n=166 participants at risk
Reported SAEs and AEs for all study participants -
Combination Therapy: Erlotinib + Sorafenib Placebo: Erlotinib + Placebo
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
84.9%
141/166 • Number of events 141
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.5%
24/166 • Number of events 24
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.0%
15/166 • Number of events 15
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.3%
37/166 • Number of events 37
|
|
Gastrointestinal disorders
Diarrhea
|
72.9%
121/166 • Number of events 121
|
|
Gastrointestinal disorders
Anorexia
|
50.6%
84/166 • Number of events 84
|
|
Skin and subcutaneous tissue disorders
Rash
|
65.7%
109/166 • Number of events 109
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
25.9%
43/166 • Number of events 43
|
|
General disorders
Fatigue
|
72.3%
120/166 • Number of events 120
|
|
Cardiac disorders
Hypertension
|
15.1%
25/166 • Number of events 25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER