Trial Outcomes & Findings for A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment (NCT NCT01990261)

NCT ID: NCT01990261

Last Updated: 2016-09-16

Results Overview

• Recruitment status: TERMINATED
• Target enrollment: 33 participants
• Primary outcome timeframe: Month 6
• Results posted on: 2016-09-16

Participant Flow

A total of 33 participants were enrolled in 13 centers in Romania.

Participant milestones

Measure	Erlotinib Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Overall Study STARTED	33
Overall Study Treated	29
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure	Erlotinib Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Overall Study Death Before Treatment Start	2
Overall Study Death due to Disease Progression (PD)	10
Overall Study Death From other Causes	1
Overall Study Disease Progression (PD)	8
Overall Study PD Before Treatment Start	1
Overall Study Dossier not Approved	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment

Baseline characteristics by cohort

Measure	Erlotinib n=33 Participants Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Age, Customized From 18 to 60 years	10 participants n=93 Participants
Age, Customized 60 years and older	23 participants n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	19 Participants n=93 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Analysis was performed on all enrolled participants.

Outcome measures

Measure	Erlotinib n=33 Participants Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Survival Rate at Month 6	33.3 percentage of participants

PRIMARY outcome

Timeframe: Month 12

Population: Analysis was performed on all enrolled participants.

Outcome measures

Measure	Erlotinib n=33 Participants Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Survival Rate at Month 12	15.2 percentage of participants

PRIMARY outcome

Timeframe: From inclusion up to disease progression or death whichever occurs first (up to 6 months)

Population: Analysis was performed on all enrolled participants.

PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.

Outcome measures

Measure	Erlotinib n=33 Participants Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Progression Free Survival (PFS) at Month 6	101.0 days Interval 55.194 to 146.806

PRIMARY outcome

Timeframe: From inclusion up to disease progression or death whichever occurs first (up to 12 months)

Population: Analysis was performed on all enrolled participants.

PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.

Outcome measures

Measure	Erlotinib n=33 Participants Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Progression Free Survival (PFS) at Month 12	121.0 days Interval 62.862 to 179.138

SECONDARY outcome

Timeframe: Up to 12 months

Population: Analysis was performed on all enrolled participants.

OS is defined as time from first administration of study drug until death from any cause.

Outcome measures

Measure	Erlotinib n=33 Participants Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Overall Survival (OS)	74.788 days Standard Error 20.823

SECONDARY outcome

Timeframe: Up to 12 months

Population: Analysis was performed on all enrolled participants.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Measure	Erlotinib n=33 Participants Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Percentage of Participants With Adverse Events (AEs)	23 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Analysis was performed on all enrolled participants.

Prior chemotherapy treatment is presented as reported by the investigators.

Outcome measures

Measure	Erlotinib n=33 Participants Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Overall Survival According to Prior Chemotherapy Treatment. Carboplatin & Gemcitabine (n=7)	191.857 days Standard Error 41.756
Overall Survival According to Prior Chemotherapy Treatment. Carboplatin & Alimta (n=1)	63.000 days Standard Error 0.000
Overall Survival According to Prior Chemotherapy Treatment. Carboplatin & Vinorelbine (n=1)	440.000 days Standard Error 0.000
Overall Survival According to Prior Chemotherapy Treatment. Gemcitabine (n=1)	30.000 days Standard Error 0.000
Overall Survival According to Prior Chemotherapy Treatment. Gemzar & Carboplatine (n=3)	127.667 days Standard Error 39.725
Overall Survival According to Prior Chemotherapy Treatment. Paclitaxel & carboplatin (CBDCA) (n=1)	80.000 days Standard Error 0.000
Overall Survival According to Prior Chemotherapy Treatment. Taxol & Carboplatin (n=1)	314.000 days Standard Error 0.000
Overall Survival According to Prior Chemotherapy Treatment. Taxotere (n=1)	336.000 days Standard Error 0.000
Overall Survival According to Prior Chemotherapy Treatment. Nabelvina & Carboplatin (n=1)	80.000 days Standard Error 0.000
Overall Survival According to Prior Chemotherapy Treatment. Carboplatin (n=1)	138.000 days Standard Error 0.000
Overall Survival According to Prior Chemotherapy Treatment. Carboplatin & Docetaxel (n=2)	222.500 days Standard Error 113.500
Overall Survival According to Prior Chemotherapy Treatment. Carboplatin & Paclitaxel (n=4)	184.875 days Standard Error 81.771
Overall Survival According to Prior Chemotherapy Treatment. Docetaxel, Gemcitabine & Cisplatin (n=1)	135.000 days Standard Error 0.000
Overall Survival According to Prior Chemotherapy Treatment. Cisplatin & Paclitaxel (n=2)	268.000 days Standard Error 61.000
Overall Survival According to Prior Chemotherapy Treatment. Docetaxel (n=1)	115.000 days Standard Error 0.000

Adverse Events

Erlotinib

Serious events: 7 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Erlotinib n=33 participants at risk Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Nervous system disorders Ischaemic stroke	3.0% 1/33 • Up to 12 months
Respiratory, thoracic and mediastinal disorders Pleural neoplasms	3.0% 1/33 • Up to 12 months
Vascular disorders Ischaemic limb pain	3.0% 1/33 • Up to 12 months
Investigations Blood bilirubin increased	3.0% 1/33 • Up to 12 months
General disorders Sudden death	3.0% 1/33 • Up to 12 months
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	3.0% 1/33 • Up to 12 months
Blood and lymphatic system disorders Anaemia of malignant disease	3.0% 1/33 • Up to 12 months
Respiratory, thoracic and mediastinal disorders Musculoskeletal chest pain	3.0% 1/33 • Up to 12 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.0% 1/33 • Up to 12 months
General disorders Disease progression	9.1% 3/33 • Up to 12 months

Other adverse events

Measure	Erlotinib n=33 participants at risk Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Skin and subcutaneous tissue disorders Rash	9.1% 3/33 • Up to 12 months

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER