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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Dacomitinib, Pemetrexed
Arm/Group Description	Pemetrexed 500mg/m2 (i.v) q21d Daco...
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

Baseline Characteristics

Arm/Group Title		Dacomitinib, Pemetrexed
Arm/Group Description		Pemetrexed 500mg/m2 (i.v) q21d Daco...
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
Baseline Analysis Population Description		...
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
White/ Caucasian		5 100.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
Austria	Number Analyzed	5 participants
Austria		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)

Outcome Measures

1.Primary Outcome


Title	Dose Limiting Toxicities (DLTs)
Description	The primary objective of this study is to determine the maximal tolera...
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.

Outcome Measure Data

Analysis Population Description

All enrolled participants


Arm/Group Title	Dacomitinib, Pemetrexed
Arm/Group Description:	Pemetrexed 500mg/m2 (i.v) q21d Daco...
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
Description	Overall Response Rate (ORR) is defined as the proportion of patients w...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Dacomitinib, Pemetrexed
Arm/Group Description:	Pemetrexed 500mg/m2 (i.v) q21d Daco...
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
Description	Overall survival (OS) defined as time from start of Dacomitinib to dat...
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.

Outcome Measure Data

Analysis Population Description

All enrolled participants


Arm/Group Title	Dacomitinib, Pemetrexed
Arm/Group Description:	Pemetrexed 500mg/m2 (i.v) q21d Daco...
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
Description	Progression-free survival (PFS) defined as time from start of Dacomiti...
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

Outcome Measure Data

Analysis Population Description

All enrolled participants


Arm/Group Title	Dacomitinib, Pemetrexed
Arm/Group Description:	Pemetrexed 500mg/m2 (i.v) q21d Daco...
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.

Adverse 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
Arm/Group Description	Pemetrexed 500mg/m2 (i.v) q21d Daco...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

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