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.
Terminated
Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| docetaxel | Docetaxel and Nintedanib | |
| docetaxel | Docetaxel and placebo | |
| placebo | Docetaxel and placebo | |
| nintedanib | Docetaxel and Nintedanib |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Docetaxel and placebo | Placebo Comparator | patients to receive backbone chemotherapy and placebo |
|
| Docetaxel and Nintedanib | Experimental | patients to receive backbone chemotherapy and nintedanib |
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 |
| Time Frame: | Up to 6 months. |
| Safety Issue: | |
| Description: | 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. |
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Boehringer Ingelheim |
March 21, 2017
