Phase II study with oral fibroblast growth factor-1 inhibitor BIBF1120 as treatment in lung carcinoma patients harboring fibroblast growth factor receptor-1 gene amplification (NVALT-15 study)

Phase 2

Completed

• Conditions: NSCLC; lung cancer; 10029107

• Registration Number: NL-OMON44999
• Lead Sponsor: Stichting NVALT studies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

* Stage IIIB or IV or recurrent NSCLC haboring a positive FISH for FGFR1 amplification.
* Age * 18 years.
* Measurable disease
* ECOG Performance Status of 0 * 1.
* Life expectancy > 3 months.

Exclusion Criteria

* Other investigational drugs or treatment in another clinical trial within the past 4 weeks.
* Chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks.
* Radiotherapy on the target lesions within the last 4 weeks.
* Previous therapy with other VEGFR inhibitors or VEGF ligand inhibitors for treatment of NSCLC.
* Symptomatic brain metastases or leptomeningeal disease..
* Radiographic evidence of cavitation or necrotic tumors.
* Centrally located tumors with radiographic evidence of local invasion of major blood vessels.
* History of clinically significant haemoptysis within the past 3 months.
* Known inherited predisposition to bleeding or thrombosis.
* Pre-existing ascites and/or clinically significant pleural effusion.
* 21. Patients who are sexually active and unwilling to use a medically acceptable method of contraception..
* Pregnancy or lactation. i

Study & Design

• Study Type: Interventional
• Study Design: Not specified