Trial Outcomes & Findings for A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer (NCT NCT00701558)

Last Updated: 2016-06-24

Results Overview

Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

From the time of randomization until disease progression or death (up to 193 weeks)]

Results posted on

2016-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Erlotinib + Gemcitabine Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Overall Study STARTED	19
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib + Gemcitabine Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Overall Study Death	7
Overall Study Lost to Follow-up	8

Baseline Characteristics

A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib + Gemcitabine n=19 Participants Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Age, Continuous	62.47 years STANDARD_DEVIATION 9.67 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the time of randomization until disease progression or death (up to 193 weeks)]

Population: Intention to treat (ITT) population included all participants who were randomized to treatment group.

Outcome measures

Outcome measures
Measure	Erlotinib + Gemcitabine n=18 Participants Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Time to Disease Progression	15 weeks Interval 7.0 to 36.0

PRIMARY outcome

Timeframe: From the time of randomization until disease progression or death (up to 193 weeks)

Population: ITT population included all participants who were randomized to treatment group.

Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Erlotinib + Gemcitabine n=19 Participants Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Overall Response Rate (ORR)	15.8 percentage of participants

SECONDARY outcome

Timeframe: From the time of randomization until death (up to 193 weeks)

Population: ITT population included all participants who were randomized to treatment group.

Overall survival was defined as the interval between the day of randomization and the date of death from any cause.

Outcome measures

Outcome measures
Measure	Erlotinib + Gemcitabine n=19 Participants Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Overall Survival	39 weeks Interval 27.0 to 51.0

Adverse Events

Erlotinib + Gemcitabine

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib + Gemcitabine n=19 participants at risk Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Gastrointestinal disorders Diarrhoea	5.3% 1/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)
Respiratory, thoracic and mediastinal disorders Respiratory tract infection	5.3% 1/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)

Other adverse events

Other adverse events
Measure	Erlotinib + Gemcitabine n=19 participants at risk Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Blood and lymphatic system disorders Anaemia of malignant disease	36.8% 7/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)
Blood and lymphatic system disorders Neutropenia	10.5% 2/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)
Blood and lymphatic system disorders Leukopenia	5.3% 1/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)
Blood and lymphatic system disorders Thrombocytopenia	31.6% 6/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)
Gastrointestinal disorders Diarrhoea	10.5% 2/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)
General disorders Fatigue	5.3% 1/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)
Investigations Blood bilirubin increased	10.5% 2/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)
Metabolism and nutrition disorders Appetite lost	5.3% 1/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)
Skin and subcutaneous tissue disorders Rash	15.8% 3/19 • Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

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