NCT00354549

Bevacizumab and Erlotinib First-Line Therapy in Advanced Non-Squamous Non-Small-Cell Lung Cancer (Stage IIIB/IV) Followed by Platinum-Based Chemotherapy at Disease Progression. A Multicenter Phase II Trial

Completed Phase 2 Last updated 13 May 2019

What this trial tests

Phase 2 trial testing bevacizumab + erlotinib hydrochloride in Lung Cancer in 104 participants. Completed in 1 September 2010.

Timeline

1 January 2006

Primary endpoint
1 April 2009

1 September 2010

Quick facts

Lead sponsor	Swiss Cancer Institute
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	104
Start date	1 January 2006
Primary completion	1 April 2009
Estimated completion	1 September 2010
Sites	2 locations across Switzerland

Drugs / interventions tested

• bevacizumab + erlotinib hydrochloride
• gemcitabine hydrochloride + cisplatin or carboplatin

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Swiss Cancer Institute

Who can join

Adults 18 to 120, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Disease stabilization (DS) (complete response [CR], partial response [PR], or stable disease [SD]) as assessed by RECIST criteria after 12 weeks of treatment with bevacizumab and erlotinib hydrochloride
  Time frame: 12 weeks

Sponsor's own description

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine at disease progression may be an effective treatment for non-small cell lung cancer.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine works in treating patients with newly diagnosed or recurrent stage IIIB or stage IV non-small cell lung cancer.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 24h-gene variation effect of combined bevacizumab/erlotinib in advanced non-squamous non-small cell lung cancer using exon array blood profiling.
   Baty F, Joerger M, Früh M, Klingbiel D, et al · · 2017 · cited 16× · PMID 28359318 · DOI 10.1186/s12967-017-1174-z
2. Iterative Upgrading of Small Molecular Tyrosine Kinase Inhibitors for EGFR Mutation in NSCLC: Necessity and Perspective.
   Zhu J, Yang Q, Xu W. · · 2021 · cited 11× · PMID 34575576 · DOI 10.3390/pharmaceutics13091500
3. EGFR exon-level biomarkers of the response to bevacizumab/erlotinib in non-small cell lung cancer.
   Baty F, Rothschild S, Früh M, Betticher D, et al · · 2013 · cited 9× · PMID 24039832 · DOI 10.1371/journal.pone.0072966
4. Cost-benefit analysis of ALK diagnosis vs. non-diagnosis in patients with advanced non-small cell lung cancer in Spain.
   Majem M, Álvarez R, Ortega AL, Ruiz de Alda L, et al · · 2022 · cited 2× · PMID 36628311 · DOI 10.33393/grhta.2022.2449