Trial Outcomes & Findings for Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer (NCT NCT00888511)

Results Overview

Progression free survival from registration according to RECIST 1.1

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

3 years

Results posted on

2020-11-27

Participant Flow

July 2007 - November 2013

Participant milestones

Participant milestones
Measure	Concurrent Tarceva and RT in LA-NSCLC Tarceva: Tarceva 150 mg/day Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concurrent Tarceva and RT in LA-NSCLC n=15 Participants Tarceva: Tarceva 150 mg/day Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks
Age, Continuous	75 years n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Region of Enrollment Denmark	15 Participants n=93 Participants

PRIMARY outcome

Timeframe: 3 years

Progression free survival from registration according to RECIST 1.1

Outcome measures

Outcome measures
Measure	Concurrent Tarceva and RT in LA-NSCLC n=15 Participants Tarceva: Tarceva 150 mg/day Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks
Progression Free Survival	9.4 months Interval 1.7 to 68.0

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: May 2012

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: May 2012

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: May 2012

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: May 2012

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: May 2012

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: May 2012

Outcome measures

Outcome data not reported

Adverse Events

Concurrent Tarceva and RT in LA-NSCLC

Serious events: 3 serious events

Other events: 0 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Concurrent Tarceva and RT in LA-NSCLC n=15 participants at risk Tarceva: Tarceva 150 mg/day Radiotherapy: 66 Gy/33 F/5 F per week for 5 weeks
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 3/15

Other adverse events

Adverse event data not reported

Additional Information

Olfred Hansen

Odense University Hospital

Phone: +45 2424 1588

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place