Phase 1
N=14
Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT02668393 ↗Enrolled (actual)
14
Serious AEs
35.7%
Results posted
Jan 2021
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel — NA milligram
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Docetaxel (Drug); Nintedanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel |
NA | — |
| PRIMARY Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle |
1; 1 | — |
Summary
Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.
Eligibility Criteria
Inclusion criteria
-Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible).
First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.
- ECOG inferior or equal to 1 at screening.
- Further inclusion criteria apply
Exclusion criteria
- Patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic NSCLC.
- Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or patients known to be positive for ALK translocation
- Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT02668393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.