Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression (NCT NCT01230710)

Last Updated: 2015-03-30

Results Overview

A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).

Results posted on

2015-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Erlotinib Participants received erlotinib 150 mg orally once a day for 48 weeks.
Overall Study STARTED	51
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	49

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib Participants received erlotinib 150 mg orally once a day for 48 weeks.
Overall Study Disease Progression	41
Overall Study Lost to Follow-up	3
Overall Study Death	4
Overall Study Withdrawal of Consent	1

Baseline Characteristics

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib n=51 Participants Participants received erlotinib 150 mg orally once a day for 48 weeks.
Age, Continuous	55.5 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).

Population: Full analysis set: All enrolled participants.

Outcome measures

Outcome measures
Measure	Erlotinib n=51 Participants Participants received erlotinib 150 mg orally once a day for 48 weeks.
Percentage of Participants With Progression-free Survival at Week 52	22.5 Percentage of participants

SECONDARY outcome

Timeframe: From the date of enrolment until the end of the study (up to 2 years, 6 months).

Population: Full analysis set: All enrolled participants.

PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.

Outcome measures

Outcome measures
Measure	Erlotinib n=51 Participants Participants received erlotinib 150 mg orally once a day for 48 weeks.
Progression-free Survival (PFS)	99 Days Interval 53.0 to 292.0

SECONDARY outcome

Timeframe: From the date of enrolment until the end of the study (up to 2 years, 6 months).

Population: Full analysis set: All enrolled participants.

Overall survival was defined as the time from the date of enrolment to the date of death from any cause.

Outcome measures

Outcome measures
Measure	Erlotinib n=51 Participants Participants received erlotinib 150 mg orally once a day for 48 weeks.
Overall Survival	671 Days Interval 392.0 to 796.0

SECONDARY outcome

Timeframe: From the date of enrolment until the end of the study (up to 2 years, 6 months).

Population: Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.

A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Erlotinib n=47 Participants Participants received erlotinib 150 mg orally once a day for 48 weeks.
Percentage of Participants With a Complete Response (CR) or a Partial Response (PR) Complete response	2.1 Percentage of participants
Percentage of Participants With a Complete Response (CR) or a Partial Response (PR) Partial response	23.4 Percentage of participants

SECONDARY outcome

Timeframe: From the date of enrolment until the end of the study (up to 2 years, 6 months).

Population: Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.

A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Erlotinib n=47 Participants Participants received erlotinib 150 mg orally once a day for 48 weeks.
Percentage of Participants With Disease Control	55.3 Percentage of participants

Adverse Events

Erlotinib

Serious events: 4 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib n=51 participants at risk Participants received erlotinib 150 mg orally once a day for 48 weeks.
Vascular disorders Deep vein thrombosis	2.0% 1/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.0% 1/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Nervous system disorders Convulsions	2.0% 1/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Injury, poisoning and procedural complications Gastrointestinal toxicity	2.0% 1/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.

Other adverse events

Other adverse events
Measure	Erlotinib n=51 participants at risk Participants received erlotinib 150 mg orally once a day for 48 weeks.
Skin and subcutaneous tissue disorders Acneiform rash	9.8% 5/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Respiratory, thoracic and mediastinal disorders Cough	7.8% 4/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Gastrointestinal disorders Diarrhoea	11.8% 6/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Skin and subcutaneous tissue disorders Dry skin	7.8% 4/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Cardiac disorders Dyspnoea	7.8% 4/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
General disorders Fever	5.9% 3/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
General disorders Generalized weakness	7.8% 4/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Nervous system disorders Headache	5.9% 3/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Skin and subcutaneous tissue disorders Itching	5.9% 3/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Skin and subcutaneous tissue disorders Maculopapular rashes	5.9% 3/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
Skin and subcutaneous tissue disorders Rashes	11.8% 6/51 Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.

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