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Non Small Cell Lung CancerPhase 2NCT01708993

Reolysin in Previously Treated Advanced/Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy

A Phase 2 study testing Pemetrexed and Reolysin (and safety run-in), Pemetrexed and Docetaxel and Reolysin in people with Non Small Cell Lung Cancer, run by Canadian Cancer Trials Group at 12 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to find out if giving reolysin in combination with docetaxel or pemetrexed can offer better results than standard therapy with docetaxel or pemetrexed alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Pemetrexed and Reolysin (and safety run-in), Pemetrexed and Docetaxel and Reolysin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
12 sitesCanada
Study dates
10 Dec 2012to 26 Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 negative).
  • 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, or patients who have had platinum based adjuvant chemotherapy after complete surgical resection 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 and the patient has received one regimen of palliative first line chemotherapy as described above.
  • 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.
  • 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 (For patients enrolled to a pemetrexed arm, the creatinine clearance must also be >45 ml/min)
  • 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 metastases)
  • Proteinuria <2g/24hrs (screen using spot testing; if ≥ grade 2 repeat with mid-stream urine; if still ≥ grade 2 then uring collection for 24 hours to confirm <2g/24hrs).
  • 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.

Who cannot join

  • 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 protocol.
  • 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 untreated brain metastases, untreated spinal cord compression or meningeal metastases are not eligible (CT scans are not required to rule this out unless there is a clinical suspicion of CNS disease). Patients with treated brain metastases who have radiologic evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).
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  • Patients who have neuropathy ≥ grade 2 (patients planned for docetaxel Arms C and D only).
  • Women must be post-menopausal, surgically sterile or use two reliable forms of contraception while on study and for 6 months 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Canada12 sites

  • BCCA - Abbotsford Centre

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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

The purpose of this study is to find out if giving reolysin in combination with docetaxel or pemetrexed can offer better results than standard therapy with docetaxel or pemetrexed alone.

Read the detailed description

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.

Being tested
Pemetrexed and Reolysin (and safety run-in), Pemetrexed, Docetaxel and Reolysin, Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pemetrexed and Reolysin (and safety run-in)Drug

    Pemetrexed: 500 mg/m², IV (10 min) - Day 1 every 3 weeks Reolysin: 4.5 x 10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks

  • PemetrexedDrug

    Pemetrexed: 500 mg/m² IV (10 min) - Day 1 every 3 weeks

  • Docetaxel and ReolysinDrug

    Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks Reolysin: 4.5x10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks

  • DocetaxelDrug

    Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks

Study groups in NCT01708993
Study groupRoleWhat they receive
Arm A: Pemetrexed and Reolysin (and safety run-in)Active comparatorNot described
Receives: Drug: Pemetrexed and Reolysin (and safety run-in)
Arm B: PemetrexedActive comparatorNot described
Receives: Drug: Pemetrexed
Arm C: Docetaxel and Reolysin (and safety run-in)Active comparatorNot described
Receives: Drug: Docetaxel and Reolysin
Arm D: DocetaxelActive comparatorNot described
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    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

    Measured: 30 months

Secondary outcomes (3)

  1. Number of patients with adverse events

    To determine the tolerability and toxicity of reolysin and standard salvage chemotherapy when given in combination.

    Measured: 30 months

  2. Response rates

    To investigate additional potential measures of efficacy including:

    • Progression rates at 3 months
    • Objective response rate
    • Overall survival (OS)

    Measured: 30 months

  3. Explore potential molecular factors predictive of response

    Exploration of potential molecular factors predictive of response by assessment of archival tumour tissue and serial blood samples.

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2012 (estimated)
  2. Study start10 Dec 2012
  3. Primary completion26 Jan 2016
  4. Study completion26 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01708993
Sponsor's protocol ID
I211
Status last verified
Apr 2020
First submitted
15 Oct 2012
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bradbury PA, Morris DG, Nicholas G, Tu D, Tehfe M, Goffin JR, Shepherd FA, Gregg RW, Rothenstein J, Lee C, Kuruvilla S, Keith BD, Torri V, Blais N, Hao D, Korpanty GJ, Goss G, Melosky BL, Mates M, Leighl N, Ayoub JP, Sederias J, Feilotter H, Seymour L, Laurie SA. Canadian Cancer Trials Group (CCTG) IND211: A randomized trial of pelareorep (Reolysin) in patients with previously treated advanced or metastatic non-small cell lung cancer receiving standard salvage therapy. Lung Cancer. 2018 Jun;120:142-148. doi: 10.1016/j.lungcan.2018.03.005. Epub 2018 Mar 9.

    PubMed 29748010

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed and Reolysin (and safety run-in), Pemetrexed and Docetaxel and Reolysin in people with Non Small Cell Lung Cancer, run by Canadian Cancer Trials Group at 12 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01708993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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