Trials / Unknown
UnknownNCT02450656
Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer
Phase I/II Study With the Combination of Afatinib and Selumetinib in Advanced KRAS Mutant Positive and PIK3CA Wildtype Non-small Cell Lung Cancer
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study investigating the progression free survival and safety of selumetinib/afatinib combination therapy compared to standard of care chemotherapy in KRASm NSCLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Afatinib | Tablet |
| DRUG | Selumetinib | Capsule |
| DRUG | Docetaxel |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2019-05-01
- Completion
- 2019-12-01
- First posted
- 2015-05-21
- Last updated
- 2018-08-27
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02450656. Inclusion in this directory is not an endorsement.