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CompletedNCT01588704Updated Jan 22, 2015

Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

A Phase 2 interventional study of Neoadjuvant Bevacizumab in Lung Cancer, sponsored by Si-Yu Wang. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-01-22.

Sponsored by Si-Yu Wang · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.

Read the detailed description

This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.

02

Conditions studied

  • Lung Cancer

Keywords

  • lung cancer
  • lung adenocarcinoma
  • bevacizumab
  • adjuvant chemotherapy
  • surgical resection rate
  • safety
  • feasibility
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.

This study's enrollment of 42 is close to the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Si-Yu Wang is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
  • No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
  • Adequate organ and bone marrow function

Exclusion criteria

Exclusion Criteria:

  • Prior chemotherapy or radiation therapy for NSCLC
  • Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
  • Patients with known hypersensitivity to other recombinant human antibodies
  • History of stroke or transient ischemic attack (TIA).
  • History of myocardial infarction or unstable angina within the past 12 months.
  • Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
  • Women who are pregnant or breast-feeding
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Neoadjuvant Bevacizumab

    Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab.

    Drug: Neoadjuvant Bevacizumab

Interventions

  • DrugNeoadjuvant Bevacizumab

    Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection

    Also known as: Pemetrexed (Alimta), Bevacizumab (Avastin)

06

What researchers measure

Primary outcomes

  1. Resectability rate

    Time frame: 3 months

Secondary outcomes

  1. Number of participants with perioperative complications

    Time frame: 4 months

  2. Disease-free survival

    Time frame: 2 years

  3. Overall survival

    Time frame: 2 years

07

Study locations

1 site
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01588704
Lead sponsor
Si-Yu Wang
Responsible party
Si-Yu Wang (Professor, Sun Yat-sen University) — Sponsor-investigator
First posted
May 1, 2012
Start date
Apr 2012
Primary completion
Jan 2014
Completion
Apr 2014
Last update
Jan 22, 2015

Study contacts

Si-Yu Wang, Doctor
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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