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Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT01918761
Recruitment Status : Terminated (poor accrual)
First Posted : August 8, 2013
Results First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Central European Cooperative Oncology Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Small Cell Lung Cancer
Intervention Drug: Dacomitinib, Pemetrexed
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dacomitinib, Pemetrexed
Hide Arm/Group Description

Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Dacomitinib, Pemetrexed
Hide Arm/Group Description

Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
All participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  60.0%
>=65 years
2
  40.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
58.0  (11.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White/ Caucasian Number Analyzed 5 participants
5
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 5 participants
5
Eastern Cooperative Oncology Group (ECOG) performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
0
4
  80.0%
1
1
  20.0%
[1]
Measure Description: 0 - Asymptomatic, 1 - Symptomatic but completely ambulatory, 2 - Symptomatic, <50% in bed during the day, 3 - Symptomatic, >50% in bed, but not bedbound, 4 - Bedbound, 5 - Death
KRAS status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Negative
1
  20.0%
Not determined
4
  80.0%
Epidermal growth factor receptor (EGFR) mutation status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Negative
1
  20.0%
Not determined
4
  80.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 5 participants
73.8  (9.68)
Heart rate  
Mean (Standard Deviation)
Unit of measure:  Bpm
Number Analyzed 5 participants
70.6  (8.62)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 5 participants
176.4  (14.26)
Temperature  
Mean (Full Range)
Unit of measure:  °C
Number Analyzed 5 participants
36.4
(36.0 to 36.8)
Body Surface Area (BSA)  
Mean (Standard Deviation)
Unit of measure:  M²
Number Analyzed 5 participants
1.9  (0.20)
Stage at primary diagnosis: Primary tumor (T)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
T0
1
  20.0%
T1b
1
  20.0%
T2a
2
  40.0%
T4
1
  20.0%
[1]
Measure Description: Tis - Carcinoma in situ, Tx - Primary Tumor cannot be assessed, T1b - Tumor > 10 mm but ≤ 20 mm in greatest dimension, T2a - Tumor > 30 mm but ≤ 40 mm in greatest dimension, T3 - Tumor > 50 mm but ≤ 70 mm in greatest dimension or tumor of any size with direct extension to chest wall, pericadium, phrenic nerve or satellite nodules in the same lobe, T4 - Tumor > 70 mm or any tumor with Invasion of mediastinum, diaphragm, heart, great vessels, recurrent laryngeal nerve, carina, trachea, oesophagus, spine or separate tumor in different lobe of ipsilateral lung
Stage at primary diagnosis: Regional lymph nodes (N)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
N0
2
  40.0%
N2
2
  40.0%
N3
1
  20.0%
[1]
Measure Description: Nx - Regional lymph nodes cannot be assessed, N0 - No regional lymph node metastases, N1 - Metastasis to ipsilateral peribronchial and/or hilar lymph nodes, N2 - Metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes, N3 - Metastasis to scalene or supraclavicular lymph nodes, metastasis to contralateral hilar or mediastinal lymph nodes
Stage at primary diagnosis: Distant metastasis (M)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
M0
1
  20.0%
M1
4
  80.0%
[1]
Measure Description: M0 - No clinical or radiographic evidence of distant metastases, M1 - Distant metastases detected, Mx - Metastases cannot be assessed.
Prior chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Yes
5
 100.0%
No
0
   0.0%
Prior surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Yes
5
 100.0%
No
0
   0.0%
Prior radiotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Yes
0
   0.0%
No
5
 100.0%
Prior antibody therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Yes
0
   0.0%
No
5
 100.0%
Electrocardiogram (ECG) results  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Abnormal
1
  20.0%
Normal
4
  80.0%
Left Ventricular Ejection Fraction (LVEF)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 5 participants
65.2  (12.28)
1.Primary Outcome
Title Dose Limiting Toxicities (DLTs)
Hide Description The primary objective of this study is to determine the maximal tolerated dose (MTD) of the combination pemetrexed + dacomitinib by the incidence of dose limiting toxicities (DLTs).
Time Frame From start of treatment to end of treatment or death, whichever occurs first. The study was suspended after 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Dacomitinib, Pemetrexed
Hide Arm/Group Description:

Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Overall Number of Participants Analyzed 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40
(5.3 to 85.3)
2.Secondary Outcome
Title Overall Response Rate
Hide Description Overall Response Rate (ORR) is defined as the proportion of patients with complete Response (CR) or partial Response (PR).
Time Frame Until progression of disease (PD) or 24 month after end of treatment for participants with no PD. The study was suspended after 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dacomitinib, Pemetrexed
Hide Arm/Group Description:

Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Overall Number of Participants Analyzed 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 52.2)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) defined as time from start of Dacomitinib to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. Patients were followed up for survival for 24 month after end of Treatment.
Time Frame until date of death. The study was suspended after 36 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Dacomitinib, Pemetrexed
Hide Arm/Group Description:

Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: months
9.6 [1] 
(2.7 to NA)
[1]
The upper confidence interval was not reached due to an insufficient number of events.
4.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival (PFS) defined as time from start of Dacomitinib to date of progression or date of death from any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients were followed up for progression-free survival for 24 month after end of Treatment.
Time Frame Up to progression or death due to any cause. The study was suspended after 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Dacomitinib, Pemetrexed
Hide Arm/Group Description:

Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: months
4.7 [1] 
(1.4 to NA)
[1]
The upper confidence interval was not reached due to an insufficient number of events.
Time Frame From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dacomitinib, Pemetrexed
Hide Arm/Group Description

Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

All-Cause Mortality
Dacomitinib, Pemetrexed
Affected / at Risk (%)
Total   3/5 (60.00%)    
Hide Serious Adverse Events
Dacomitinib, Pemetrexed
Affected / at Risk (%) # Events
Total   4/5 (80.00%)    
Cardiac disorders   
Dyspnoea  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Diarrhoea  1  1/5 (20.00%)  1
Investigations   
General physical condition abnormal  1  1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Dermatitis acneiform  1  1/5 (20.00%)  1
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dacomitinib, Pemetrexed
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  2/5 (40.00%)  6
Neutropenia  1  1/5 (20.00%)  4
Thrombocytopenia  1  1/5 (20.00%)  3
Cardiac disorders   
Dyspnoea  1  1/5 (20.00%)  1
Eye disorders   
Eye infection  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Abdominal pain upper  1  1/5 (20.00%)  1
Aphthous ulcer  1  1/5 (20.00%)  1
Burning mouth syndrome  1  1/5 (20.00%)  1
Diarrhoea  1  5/5 (100.00%)  11
Nausea  1  3/5 (60.00%)  3
Stomatitis  1  2/5 (40.00%)  2
General disorders   
Fatigue  1  4/5 (80.00%)  5
Oedema peripheral  1  1/5 (20.00%)  1
Pyrexia  1  2/5 (40.00%)  2
Immune system disorders   
Symmetrical drug-related intertriginous and flexural exanthema  1  2/5 (40.00%)  6
Investigations   
General physical condition abnormal  1  1/5 (20.00%)  1
Neutrophil count decreased  1  1/5 (20.00%)  2
Platelet count decreased  1  1/5 (20.00%)  3
White blood cell count decreased  1  1/5 (20.00%)  3
Metabolism and nutrition disorders   
Decreased appetite  1  1/5 (20.00%)  2
Weight loss poor  1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/5 (20.00%)  2
Pain in extremity  1  1/5 (20.00%)  2
Nervous system disorders   
Polyneuropathy  1  1/5 (20.00%)  1
Dysgeusia  1  1/5 (20.00%)  3
Psychiatric disorders   
Depression  1  1/5 (20.00%)  1
Insomnia  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Dermatitis acneiform  1  1/5 (20.00%)  2
Nail bed inflammation  1  1/5 (20.00%)  1
Paronychia  1  1/5 (20.00%)  1
Pruritus  1  2/5 (40.00%)  2
Rash  1  1/5 (20.00%)  1
Scrotal ulcer  1  1/5 (20.00%)  3
Skin fissures  1  1/5 (20.00%)  2
Skin hyperpigmentation  1  1/5 (20.00%)  1
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: MD Christiane Thallinger
Organization: Cecog
Phone: +43 1 409 77 25
EMail: office@cecog.at
Layout table for additonal information
Responsible Party: Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01918761    
Other Study ID Numbers: CECOG/ NSCLC.1.1.001
First Submitted: May 27, 2013
First Posted: August 8, 2013
Results First Submitted: November 21, 2019
Results First Posted: December 30, 2019
Last Update Posted: December 30, 2019