Overview

A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC

Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non-squamous Non-Small Cell Lung Cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Helix BioPharma Corporation
Collaborator:
Theradex
Treatments:
Carboplatin
Immunoconjugates
Pemetrexed
Criteria
Main Inclusion Criteria:

1. Male or female patient ≥ 18 years of age

2. Histologically or cytologically confirmed non-squamous NSCLC

3. EGFR-mutation positive patients must have progressed on or had intolerance to an EGFR
small molecule tyrosine kinase inhibitor

4. Patients whose tumors harbor an anaplastic lymphoma kinase (ALK) translocation must
have progressed on or had intolerance to an ALK inhibitor;

5. No prior adjuvant chemotherapy within 1 year of the first treatment day if there is
recurrent disease

6. At least 1 site of measurable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and minimum
life expectancy of ≥ 3 months

8. Adequate bone marrow, renal and liver function

Main Exclusion Criteria:

1. Histologic evidence of predominantly squamous cell NSCLC

2. Brain metastasis and/or leptomeningeal disease (known or suspected)

3. Peripheral neuropathy > CTCAE grade 1

4. Possibility of a curative local treatment (surgery and/or radiotherapy)

5. Previous chemotherapy except adjuvant treatment with progression of disease documented
≥ 12 months after end of adjuvant treatment

6. Having received treatment in another clinical study within the 30 days prior to
commencing study treatment or having side effects of a prior study drug that are not
recovered to grade ≤ 1 or baseline, except for alopecia

7. Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy