Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.
Interventions
DRUGdocetaxel
intravenous chemotherapy drug
DRUGplacebo
oral placebo
DRUGnintedanib
oral experimental therapy
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients of at least 18 years of age * Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy.
Exclusion criteria
* More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease. * Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation * Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any time * Prior monotherapy with an EGFR inhibitor except as maintenance therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | Up to 6 months. | This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease. |
Countries
Georgia, Thailand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. | 6 |
| Nintedanib Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m\^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lack of Efficacy | 4 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | Nintedanib | Total |
|---|---|---|---|
| Age, Continuous | 59.7 Years STANDARD_DEVIATION 12.2 | 63.3 Years STANDARD_DEVIATION 8.3 | 61.5 Years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 6 / 6 |
| serious Total, serious adverse events | 3 / 6 | 3 / 6 |
Outcome results
Primary
Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.
Time frame: Up to 6 months.
Population: Randomised Set: The randomised set included all randomised patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | Yes | 66.7 Percentage of participants |
| Placebo | Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | No | 33.3 Percentage of participants |
| Nintedanib | Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | Yes | 50.0 Percentage of participants |
| Nintedanib | Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | No | 50.0 Percentage of participants |