A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
CompletedPhase 2Results postedLast updated 12 September 2018
What this trial tests
Phase 2 trial testing Erlotinib in Non-Squamous Non-Small Cell Lung Cancer in 208 participants. Completed in 30 December 2016.
18 and older, any sex, with Non-Squamous Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival Per RECIST, v. 1.1 (PFS1)Primary· Approximately 68 months
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Group
Value
95% CI
Erlotinib
11.000
9.267 – 11.200
Progression-free Survival Per Investigator (PFS2)Secondary· Approximately 68 months
PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation.
Group
Value
95% CI
Erlotinib
15.000
13.067 – 18.700
Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858RSecondary· Approximately 68 months
ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
All Participants
Group
Value
95% CI
Erlotinib
72.3
64.3 – 79.3
EGFR Mutation E19del or L858R
Group
Value
95% CI
Erlotinib
72.9
64.9 – 80.0
Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858RSecondary· Approximately 68 months
DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 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 sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute incr
All Participants
Group
Value
95% CI
Erlotinib
84.5
77.6 – 89.9
EGFR Mutation E19del or L858R
Group
Value
95% CI
Erlotinib
85.4
78.6 – 90.7
Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)Secondary· Approximately 68 months
PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Group
Value
95% CI
Erlotinib
11.000
9.267 – 11.200
Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858RSecondary· Approximately 68 months
OS was defined as the time from baseline to the date of death from any cause.
All Participants
Group
Value
95% CI
Erlotinib
31.633
28.100 – 36.133
EGFR Mutation E19del or L858R
Group
Value
95% CI
Erlotinib
31.800
28.100 – 36.133
Number of Participants With Adverse EventsSecondary· Approximately 68 months
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Group
Value
95% CI
Erlotinib
206
Adverse events — posted to ClinicalTrials.gov
Time frame: Approximately 68 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06545695 — Epidermal Growth Factor Receptor Inhibition for Keratinopathies
· Phase 1, PHASE2
· not yet recruiting
NCT06161558 — Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors
· Phase 1
· withdrawn
NCT05827614 — Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With
· Phase 1
· active not recruiting
NCT04981509 — Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer
· Phase 2
· recruiting
NCT03110484 — Pemetrexed in Combination With Erlotinib as a Salvage Treatment in Patients With Metastatic Biliary Tract Cancer (BTC) W
· Phase 2
· unknown
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Currently open trials in the same condition.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 12 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01310036.