A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 3, 2024 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Helix BioPharma Corporation
- Interventions being studied
- Drug: L-DOS47
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
Main 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
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University Hospitals Case Medical CenterCleveland, Ohio
- The University of Texas MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 3, 2024. Always confirm current availability with the study team.