Phase 1
N=16
A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology.
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT01346540 ↗Enrolled (actual)
16
Serious AEs
43.8%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities (DLTs) During First Cycle for the Determination of the Maximum Tolerated Dose (MTD) — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BIBF 1120 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) During First Cycle for the Determination of the Maximum Tolerated Dose (MTD) |
0; 0 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Nintedanib Added to Cisplatin/Gemcitabine Based on the Occurrence of DLTs During Treatment Cycle 1. |
200 | — |
| SECONDARY Incidence of Adverse Events (AEs) According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00 |
0; 0; 0; 0; 1; 8 | — |
Summary
The LUME-Lung3 study is in 2 parts:
Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and cisplatin.
Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2 previous courses of the chemotherapy
Eligibility Criteria
Inclusion criteria
Run-in Phase I
- Histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent Non Small Cell Lung Cancer (NSCLC) with squamous cell histology.
- Measurable disease according to Response Evaluation Criteria in Solid Tumours ( RECIST 1.1).
- Patient Eastern Cooperative Oncology Group (ECOG) score of 0-1.
- Male or female patients age = 18 years.
- Life expectancy of at least three (3) months.
- Written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.
Phase II - in addition to the above criteria:
- Radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin / gemcitabine chemotherapy.
Exclusion criteria
- Prior therapy for advanced or metastatic or recurrent Non Small Cell Lung Cancer (NSCLC). One prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization
- Prior treatment with other Vascular Endothelial Growth Factor Receptor (VEGFR) inhibitors (other than bevacizumab)
- Any contraindications for treatment with gemcitabine and/or cisplatin.
- Use of any investigational drug within 4 weeks of entering the 1199.82 study.
- History of major thrombotic or clinically relevant bleeding event in the past 6 months.
- Significant cardiovascular diseases (i.e. hypertension not controlled by medication.
- Surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing.
- Active brain metastases
- Radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis < 4 weeks prior baseline imaging.
- Any other current malignancy or malignancy diagnosed within the past five (5) years.
Data sourced from ClinicalTrials.gov (NCT01346540). 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.