A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC (NCT02309892) | Clinical Trial Compass
TerminatedPhase 1
A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
Stopped: Slow enrolment - standard of care evolved over the duration of the study such that treatment regimen employed in the study was no longer current standard of care for first line resulting in recruitment challenges.
United States14 participantsStarted 2015-04-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female patient ≥ 18 years of age
✓. Histologically or cytologically confirmed non-squamous NSCLC
✓. EGFR-mutation positive patients must have progressed on or had intolerance to an EGFR small molecule tyrosine kinase inhibitor
✓. Patients whose tumors harbor an anaplastic lymphoma kinase (ALK) translocation must have progressed on or had intolerance to an ALK inhibitor;
✓. No prior adjuvant chemotherapy within 1 year of the first treatment day if there is recurrent disease
✓. At least 1 site of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and minimum life expectancy of ≥ 3 months
✓. Adequate bone marrow, renal and liver function
Exclusion criteria
✕. Histologic evidence of predominantly squamous cell NSCLC
What they're measuring
1
Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin
Timeframe: Up to 12 weeks
2
Number of Participants With Dose Limited Toxicities (DLTs) Related to L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin.
Timeframe: Up to 21 days
3
Maximum Tolerated Dose of L-DOS47 in Combination With Pemetrexed/Carboplatin
✕. Brain metastasis and/or leptomeningeal disease (known or suspected)
✕. Peripheral neuropathy \> CTCAE grade 1
✕. Possibility of a curative local treatment (surgery and/or radiotherapy)
✕. Previous chemotherapy except adjuvant treatment with progression of disease documented ≥ 12 months after end of adjuvant treatment
✕. 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
✕. Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy