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A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.

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

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Trial Information

A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.

Reolysin is a virus which has been shown to target and destroy cancer cells in laboratory
tests. Reolysin has been studied in over 360 cancer patients to find safe doses that can be
given and has also undergone testing in combination with docetaxel.

Docetaxel and pemetrexed have anticancer activity in certain cancers including lung and they
have been approved by Health Canada for the treatment of patients with advanced or
metastatic non-small cell lung cancer.

Researchers doing this study also want to evaluate the side effects of reolysin when given
together with docetaxel or pemetrexed.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed diagnosis of non-small
cell lung cancer (NSCLC). As treatment arm is assigned based on histology subtype, it
must be feasible to subtype into squamous or other.

- All patients must have a formalin fixed paraffin embedded tissue block (from primary
or metastatic tumour) available for translational studies and must have provided
informed consent for the release of the block as well as for blood samples for
correlative studies.

- Presence of clinically and/or radiologically documented disease. At least one site of
disease must be unidimensionally measurable as follows:

- Chest X-ray ≥ 20 mm

- CT/MRI scan (with slice thickness of < 5 mm) ≥ 10 mm --> longest diameter

- Physical exam (using calipers) ≥ 10 mm

- Lymph nodes by CT scan ≥ 15 mm --> measured in short axis All radiology studies
must be performed within 28 days prior to randomization (within 35 days if

- Patients must have advanced and or metastatic disease, for which no curative therapy
exists and for which systemic therapy is indicated.

- ECOG performance of 0 or 1.

- Age ≥ 18 years.

Surgery: Previous major surgery is permitted provided that it has been at least 14 days
prior to patient randomization and that wound healing has occurred.

Chemotherapy: Patients must have received one regimen of palliative first line
chemotherapy (must be platinum containing combination unless patient's age > 70 years)
which may not have contained docetaxel. Patients who have had concurrent platinum based
chemoradiotherapy for stage three disease and have relapsed within one year of treatment
may be considered to have had one prior platinum containing regimen. Prior paclitaxel is
permissible. Patients who have had prior pemetrexed for first line therapy will be
randomized to Treatment Arm C or D (docetaxel ± reolysin). Prior maintenance therapy with
pemetrexed is not permitted. Prior adjuvant chemotherapy is permissible providing
completed at least 1 year prior to relapse/recurrence of disease.

Other Therapy: Patients may have received other therapies including immunotherapy, or with
signal transduction inhibitors, including EGFR inhibitors.

Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks has
elapsed between the last dose and enrollment to the trial. Exceptions may be made for low
dose, non-myelosuppressive radiotherapy after consultation with NCIC CTG.

- Laboratory Requirements (must be done within 7 days prior to randomization)

- Hematology:

- Neutrophils ≥ 1.5 x 10^9/L

- Platelets ≥ 100 x 10^9/L

- Biochemistry:

- Serum creatinine ≤ 1.5 x ULN

- Total bilirubin ≤ 1.0 x ULN (unless elevated secondary to conditions such as
Gilbert's disease)

- ALT and AST ≤ 1.5 x ULN (≤ 3x ULN is permitted in the presence of known liver

- Patient consent must be appropriately obtained in accordance with applicable local
and regulatory requirements. Each patient must sign a consent form prior to
enrollment in the trial to document their willingness to participate.

Patients who cannot give informed consent (i.e. mentally incompetent patients, or those
physically incapacitated such as comatose patients) are not to be recruited into the
study. Patients competent but physically unable to sign the consent form may have the
document signed by their nearest relative or legal guardian. Each patient will be provided
with a full explanation of the study before consent is requested.

- Patients must be accessible for treatment and follow-up. Patients registered on this
trial must be treated and followed at the participating centre. This implies there
must be reasonable geographical limits (for example: 2 hour's driving distance)
placed on patients being considered for this trial. Investigators must assure
themselves that the patients registered on this trial will be available for complete
documentation of the treatment, adverse events, response assessment and follow-up.

- In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working
days of patient randomization.

Exclusion Criteria:

- Patients with a history of other malignancies, except for adequately treated
non-melanoma skin cancer or solid tumours curatively treated with no evidence of
disease for > 3 years.

- Patients who are on immunosuppressive therapy or have known HIV infection or active
hepatitis B or C.

- Patients with active or uncontrolled infections or with serious illnesses or medical
conditions which would not permit the patient to be managed according to the

- Patients with significant cardiac (including uncontrolled hypertension) or pulmonary
disease, or active CNS disease or infection.

- Patients with a known hypersensitivity to the study drug(s) or their components.

- Patients with history of central nervous system metastases or untreated spinal cord

- Patients who have neuropathy ≥ grade 2 (patients planned for docetaxel Arms C and D

- Women must be post-menopausal, surgically sterile or use two reliable forms of
contraception while on study and for 90 days after discontinuing therapy. Women of
childbearing potential must have a pregnancy test taken and proven negative within 7
days prior to registration/randomization and must not be lactating. Men must be
surgically sterile or use a barrier method of contraception.

- Concurrent treatment with other investigational drugs or anti-cancer therapy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

Evaluation of the effect of reolysin in combination with standard salvage chemotherapy on the progression free survival of patients with advanced or metastatic NSCLC. Response and progression will be evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee

Outcome Time Frame:

30 months

Safety Issue:


Principal Investigator

Donald G Morris

Investigator Role:

Study Chair

Investigator Affiliation:

Tom Baker Cancer Centre, Calgary Alberta Canada


Canada: Health Canada

Study ID:




Start Date:

November 2012

Completion Date:

April 2015

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms