Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin for Non-Small Cell Lung Cancer With KRAS or EGFR Activation

Study summary

The purpose of this Phase 2 study is to investigate whether intravenous administration of a wild type reovirus (REOLYSIN®) in combination with paclitaxel and carboplatin is effective and safe in the treatment of Non-Small Cell Lung Cancer with KRAS or EGFR activation.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedREOLYSIN® and Carboplatin

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 2, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Oncolytics Biotech

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Oncolytics Biotech
Interventions being studied: Biological: REOLYSIN®; Drug: Carboplatin; Drug: Paclitaxel

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Biomarkers

EGFR→KRAS→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

have histologically or cytologically confirmed stage IIIB (pleural effusion; IVA on revised IASLC staging) or stage IV, or recurrent, non-small cell lung cancer with evidence of RAS- or EGFR- activation in their tumors, as defined by EGFR activating mutations in exons 18 to 21, EGFR FISH amplification, or K-ras mutations in exon 2 (codons 12,13,61).
have evidence of measurable disease. For patients previously irradiated, the measurable lesion(s) must be outside of the treated field.
be chemotherapy naïve for their metastatic or recurrent NSCLC. Prior adjuvant chemotherapy or chemo-XRT for treatment of localized disease is allowed, provided it has been ≥ 6 months since the last chemotherapy infusion. Previous radiation for palliative purposes is also allowed, as long as it has been ≥4 weeks from the last dose.
Patients who have been previously treated with EGFR tyrosine kinase inhibitors as their only systemic treatment are eligible, provided this treatment has been discontinued for ≥4 weeks. Patients who have received erlotinib as first line treatment without chemotherapy and experience tumor progression will be eligible.
have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy, chemotherapy, or surgical procedures, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) Grade ≤ 1. Surgery (except biopsies) must have occurred at least 28 days prior to study enrollment.
have an ECOG Performance Score of ≤ 2.
have a life expectancy of at least 3 months.
have baseline laboratory results as follows:
Absolute neutrophil count (ANC) ≥ 1.5 x 10E9 \[SI units 10\^9/L\]
Platelets ≥ 100 x10E9 \[SI units 10E9/L\] (without platelet transfusion)
Hemoglobin ≥ 9.0 g/dL \[SI units gm/L\] (with or without RBC transfusion)
Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
Bilirubin ≤ 1.5 x ULN
AST/ALT ≤ 2.5 x ULN
Negative pregnancy test for females of childbearing potential.
be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.

Reasons someone may not be able to joinExclusion criteria

Receive concurrent therapy with any other anticancer agent while on study.
Received chemotherapy within 6 months, or radiotherapy or EGFR therapy within 4 weeks, prior to entering the study or have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Have brain metastases. Patients with resected oligometastasis are eligible if post resection MRI demonstrates resolution. Gamma knife treated patients are also eligible, if there are no more than two treated metastases confined to the same area of the brain and a post treatment MRI shows a decrease in the metastases.
Have ≥ grade 2 peripheral neuropathy at baseline.
Have uncontrolled cardiac dysfunction, including a myocardial infarction in the preceding 6 months, or known cardiac ejection fraction \< 40%.
Be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
Be a pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception.
Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements.
Have dementia or altered mental status that would prohibit informed consent.
Have any other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Georgetown University Medical CenterWashington D.C., District of Columbia
The Ohio State University Medical Center, James Cancer Hospital and Solove Research InstituteColumbus, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 2, 2015. Always confirm current availability with the study team.

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