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A Phase 2 Trial of Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D

Phase 2
18 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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Trial Information

A Phase 2 Trial of Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D

Inclusion Criteria:

- Pathologic or cytologic evidence of non-small cell lung cancer (NSCLC)

- Documented KRAS mutation

- History of smoking < 100 cigarettes (never-smoker) OR patient with a KRAS G12D
mutation regardless of smoking history

- Clinical stage IIIB/IV or recurrent/medically inoperable NSCLC

- Age ≥ 18 years

- Three (3) weeks since last chemotherapy, and three (3) weeks since prior radiation
therapy and recovered from treatment

- Karnofsky performance status ≥ 70%

- Adequate hematologic, and/or hepatic function WBC ≥ 3,000/ul or absolute neutrophil
count ≥ 1,000/ul Hemoglobin ≥ 9.0 g/dl Platelet count ≥ 100,000/ul AST ≤ 2.0 X ULN
(upper limit of normal)

- Total bilirubin ≤1.5 x ULN Measurable indicator lesions by RECIST v1.1 criteria.

- Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care.

- Female subject is either postmenopausal for at least 1 year before the screening
visit, is surgically sterilized or if they are of childbearing potential, agree to
practice 2 effective methods of contraception from the time of signing the informed
consent form through 30 days after the last dose of bortezomib, or agree to
completely abstain from heterosexual intercourse.

- Male subjects must agree to 1 of the following: practice effective barrier
contraception during the entire study treatment period and through a minimum of 30
days after the last dose of study drug, or completely abstain from heterosexual

Exclusion Criteria:

- Uncontrolled central nervous system metastases defined as any lesion which is either
a. symptomatic, or requiring escalating doses of corticosteroids

- Significant medical history or unstable medical condition such as uncontrolled
diabetes myocardial infarction within 6 months prior to enrollment New York Heart
Association Class III or IV heart failure severe uncontrolled ventricular arrythmias
uncontrolled angina ECG evidence of acute ischemia or active conduction system

- Baseline ≥ grade 2 peripheral neuropathy by CTCAE v 4.0 (Appendix B)

- Known hypersensitivity to boron or mannitol

- Female patients who are pregnant/lactating or have a positive serum or urine β-hCG
pregnancy test

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

- No active concurrent malignancy, with the exception of in-situ malignancy completely
resected basal cell carcinoma or squamous cell carcinomas of the skin low-risk
prostate cancer after curative therapy

- Participation in clinical trials with other investigational agents not included in
this trial, within 14 days of the start of this trial and throughout the duration of
this trial

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy of single-agent subcutaneous bortezomib

Outcome Description:

The following evaluations will be conducted to assess the efficacy of bortezomib - radiographic response rate by RECIST v1.1

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Gregory Riely, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • KRAS-Mutant
  • Bortezomib
  • KRAS G12D
  • 12-222
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Mercy Medical CenterRockville Centre, New York  11570
Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memoral Sloan Kettering Cancer Center at PhelpsSleepy Hollow, New York  10591