Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Non-small-cell lung cancer (NSCLC)
Brief summary
This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR. This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).
Interventions
DRUGErlotinib
150 mg oral dose of erlotinib given once daily
DRUGChemotherapy
Cisplatin (75 mg/m\^2 intravenously \[IV\]) on Day 1 and gemcitabine (1250 mg/m\^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant in ENSURE trial * Disease progression during first-line treatment
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events | within 3 years, 9 months (data cut-off December 2014) | Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Participants With Adverse Events | start of second-line treatment to data cut-off in December 2014 (within 12 months) |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib-Chemotherapy Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment | 21 |
| Chemotherapy-Erlotinib Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment | 24 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued due to data cut-off | 3 | 8 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Chemotherapy-Erlotinib | Erlotinib-Chemotherapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 17 Participants | 35 Participants |
| Age, Continuous | 57.0 years STANDARD_DEVIATION 11.32 | 57.8 years STANDARD_DEVIATION 8.2 | 57.3 years STANDARD_DEVIATION 9.88 |
| Region of Enrollment China | 24 participants | 21 participants | 45 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 14 Participants | 9 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 21 | 12 / 24 |
| serious Total, serious adverse events | 0 / 21 | 1 / 24 |
Outcome results
Primary
Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.
Time frame: within 3 years, 9 months (data cut-off December 2014)
Population: Intention to treat population, defined as all participants enrolled in this extension study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib-Chemotherapy | Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events | 26.3 Months |
| Chemotherapy-Erlotinib | Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events | 23.4 Months |
p-value: >0.0595% CI: [0.61, 2.62]Log Rank
Secondary
Participants With Adverse Events
Time frame: start of second-line treatment to data cut-off in December 2014 (within 12 months)
Population: Safety Population, defined as all participants enrolled in this extension study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib-Chemotherapy | Participants With Adverse Events | With any serious AEs (SAEs) | 0 participants |
| Erlotinib-Chemotherapy | Participants With Adverse Events | With any AEs leading to study drug withdrawal | 0 participants |
| Erlotinib-Chemotherapy | Participants With Adverse Events | With any drug related (possible/probable) AEs | 10 participants |
| Erlotinib-Chemotherapy | Participants With Adverse Events | With any AEs leading to death | 0 participants |
| Erlotinib-Chemotherapy | Participants With Adverse Events | With any AEs Grade ≥ 3 | 5 participants |
| Erlotinib-Chemotherapy | Participants With Adverse Events | With AEs of Special Interest | 0 participants |
| Erlotinib-Chemotherapy | Participants With Adverse Events | With any drug related (possible/probable) SAEs | 0 participants |
| Erlotinib-Chemotherapy | Participants With Adverse Events | With pregnancy | 0 participants |
| Erlotinib-Chemotherapy | Participants With Adverse Events | With any adverse events (AEs) | 14 participants |
| Chemotherapy-Erlotinib | Participants With Adverse Events | With pregnancy | 0 participants |
| Chemotherapy-Erlotinib | Participants With Adverse Events | With any adverse events (AEs) | 12 participants |
| Chemotherapy-Erlotinib | Participants With Adverse Events | With any serious AEs (SAEs) | 1 participants |
| Chemotherapy-Erlotinib | Participants With Adverse Events | With any AEs Grade ≥ 3 | 2 participants |
| Chemotherapy-Erlotinib | Participants With Adverse Events | With any drug related (possible/probable) AEs | 9 participants |
| Chemotherapy-Erlotinib | Participants With Adverse Events | With any drug related (possible/probable) SAEs | 0 participants |
| Chemotherapy-Erlotinib | Participants With Adverse Events | With any AEs leading to study drug withdrawal | 0 participants |
| Chemotherapy-Erlotinib | Participants With Adverse Events | With any AEs leading to death | 0 participants |
| Chemotherapy-Erlotinib | Participants With Adverse Events | With AEs of Special Interest | 0 participants |