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Status unknownNCT00801385Updated Aug 25, 2009

Sorafenib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Chemotherapy

A Phase 2 interventional study of erlotinib hydrochloride and sorafenib tosylate in Lung Cancer, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-25.

Sponsored by Yonsei University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
47
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to chemotherapy.

Read the detailed description

OBJECTIVES:

Primary

  • To assess the response rate of sorafenib tosylate in combination with erlotinib hydrochloride in patients with stage IIIB-IV non-small cell lung cancer refractory to 1 or 2 prior chemotherapy regimens.

Secondary

  • To assess the response duration in patients treated with this regimen.
  • To assess the disease control rate in patients treated with this regimen.
  • To assess the progression-free survival of patients treated with this regimen.
  • To assess the overall survival of patients treated with this regimen.
  • To assess the safety and tolerability of this regimen in these patients.
  • To analyze biomarkers, including evaluation of EGFR expression, mutational analysis of EGFR and K-ras, and immunohistochemical analysis of EGFR downstream pathway (phospho-EGFR, phospho-AKT, phospho-Erk, phospho-STAT3).

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tissue samples are analyzed at the nucleic acid level for EGFR mutation (exon 18-21) and K-ras mutation (exon 2), DNA mutations via PCR, presence of EGFR protein by IHC, and downstream effectors of EGFR activation by IHC.

After completion of study therapy, patients are followed periodically.

02

Conditions studied

  • Lung Cancer

Keywords

  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's planned enrollment of 47 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer

    • Advanced (stage IIIB-IV) or recurrent disease
  • Must have failed 1 or 2 prior chemotherapy regimens, including platinum-containing regimen
  • At least 1 unidimensionally measurable lesion > 10 mm by spiral CT scan or > 20 mm by conventional CT scan

    • Previously irradiated lesions cannot be included as sites of measurable disease unless clear tumor progression has been documented in the lesions since the end of radiotherapy
  • No known or suspected brain metastases

    • Patients with clinical signs or symptoms that are suspicious of brain metastasis must have a pre-treatment CT scan or MRI of the brain
    • Patients with prior brain metastases are eligible provided they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • WBC 4,000-12,000/μL
  • Neutrophil ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.0 times ULN
  • Alkaline phosphatase ≤ 2.0 times ULN
  • Serum creatinine ≤ 1.5 times ULN
  • Not pregnant or nursing
  • No active clinically serious infections
  • No prior or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1), or any cancer curatively treated > 5 years before study
  • Able to swallow oral medications
  • No substance abuse or medical, psychological, or social conditions that may interfere with participation in the study or evaluation of the study results

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • No prior anti-EGFR targeted therapy
  • At least 4 weeks since prior surgery
  • At least 4 weeks since prior and no concurrent radiotherapy

    • No prior radiotherapy to the whole pelvis or chest or to ≥ 25% of the bone marrow
  • No other concurrent anticancer agents (e.g., chemotherapy or immunotherapy agents) which might affect evaluation of study treatment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
47 participants (estimated)

Interventions

  • Drugerlotinib hydrochloride
  • Drugsorafenib tosylate
  • GeneticDNA analysis
  • Geneticmutation analysis
  • Geneticpolymerase chain reaction
  • Geneticprotein analysis
  • Geneticprotein expression analysis
  • Otherimmunohistochemistry staining method
  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Tumor response based on RECIST criteria

Secondary outcomes

  1. Response duration in patients with confirmed objective response

  2. Disease control rate

  3. Overall survival

  4. Progression-free survival

  5. Biomarker analysis

07

Study locations

1 of 1 sites recruiting
  • Yonsei Cancer Center at Yonsei University Medical Center
    Seoul, 120-752, Korea, Republic of
    Recruiting
08

References and documents

Publications

  • Lim SM, Cho BC, Kim SW, Kang SY, Heo DS, Kim HT, Lee DH, Kim DW, Jung M, Choi JH, Shim HS, Choi JR, Kim JH. A multicenter phase II study of sorafenib in combination with erlotinib in patients with advanced non-small cell lung cancer (KCSG-0806). Lung Cancer. 2016 Mar;93:1-8. doi: 10.1016/j.lungcan.2015.12.005. Epub 2015 Dec 29. PubMed 26898607 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00801385
Lead sponsor
Yonsei University
First posted
Dec 3, 2008
Start date
Sep 2008
Primary completion
Jun 2009 (estimated)
Last update
Aug 25, 2009

Study contacts

Joo-Hang Kim, MD
principal investigator · Yonsei University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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