Clinical trial · Interventional
Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
An Open Label Phase I of Oral Nintedanib Plus Weekly Docetaxel Therapy in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma After Failure of Platinum -Based First Line Chemotherapy
NCT02668393CI-TRIAL-00049705completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Nintedanib | Drug | Nintedanib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Level 0
- description
- Nintedanib low dose with docetaxel
- interventionNames
- Drug: Docetaxel
- Drug: Nintedanib
- type
- OTHER
- label
- Level 1
- description
- Nintedanib medium dose with docetaxel
- interventionNames
- Drug: Docetaxel
- Drug: Nintedanib
- type
- OTHER
- label
- Level 2
- description
- Nintedanib high dose with docetaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.