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History of Changes for Study: NCT02309892
A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
Latest version (submitted February 20, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 3, 2014 None (earliest Version on record)
2 December 5, 2014 Arms and Interventions and Study Status
3 August 26, 2015 Study Status and Contacts/Locations
4 February 19, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 March 17, 2017 Study Status
6 August 11, 2017 Study Status and Contacts/Locations
7 March 13, 2019 Study Status
8 March 18, 2019 Contacts/Locations and Study Status
9 February 20, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02309892
Submitted Date:  December 3, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: LDOS001
Brief Title: A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
Official Title: A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination With Pemetrexed/Carboplatin in Patients With Stage IV (TNM M1a and M1b) Recurrent or Metastatic NSCL Lung Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2014
Overall Status: Active, not recruiting
Study Start: April 2014
Primary Completion: March 2016 [Anticipated]
Study Completion: August 2016 [Anticipated]
First Submitted: April 9, 2013
First Submitted that
Met QC Criteria:
December 3, 2014
First Posted: December 5, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 3, 2014
Last Update Posted: December 5, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Helix BioPharma Corporation
Responsible Party: Sponsor
Collaborators: Theradex
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
Detailed Description: It is planned that patients will receive 4 cycles of combination treatment with L-DOS47 + pemetrexed/carboplatin. Patients who have not progressed following the 4 cycles of combination treatment and who have not experienced unacceptable toxicity will have the opportunity to continue to receive L-DOS47 treatment for as long as there is clinical benefit and it is well-tolerated, in the opinion of the Investigator, until disease progression. Patients who are unable to complete 4 cycles of L-DOS47 + pemetrexed/carboplatin combination treatment due to pemetrexed/carboplatin toxicity will have the opportunity to continue receiving L-DOS47 treatment following discontinuation of pemetrexed/carboplatin, for as long as there is clinical benefit and it is well-tolerated, in the opinion of the Investigator, until disease progression.
Open or close this module Conditions
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Neoplasms
Immunoconjugate
Tumor microenvironment alkalinization
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Drug: L-DOS47
A treatment cycle will be 21 days, with patients receiving L DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle.
Other Names:
  • Pemetrexed/Carboplatin
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of patients with adverse events as a measure safety and tolerability of L-DOS47 in combination treatment with pemetrexed/carboplatin
[ Time Frame: Participants will be followed for 12 weeks ]

The AE reporting period starts on Cycle 1 Day 1 up to the last study visit.
Secondary Outcome Measures:
1. Objective response rate of patients receiving the combination treatment according to RECIST 1.1
[ Time Frame: Up to 12 weeks ]

Objective tumor response will be assessed according to RECIST version 1.1 in patients who have completed at least 2 cycles of study treatment and who have at least 1 post-treatment disease assessment.
2. Number of patient receiving a sustained clinical benefit
[ Time Frame: Up to 12 weeks ]

Defined as the percentage of patients who have achieved complete response, partial response, and stable disease following combination treatment with L-DOS47 + pemetrexed/carboplatin.
3. Maximum observed plasma concentration (Cmax) of L-DOS47 after dosing in combination treatment with pemetrexed/carboplatin
[ Time Frame: Up to 12 weeks ]

Pharmacokinetic parameters for L-DOS47 will be determined from plasma samples collected from all patients dosed with L-DOS47
4. Time to maximum observed plasma concentration (Tmax) of L-DOS47 after dosing in combination treatment with pemetrexed/carboplatin
[ Time Frame: Up to 12 weeks ]

Pharmacokinetic parameters for L-DOS47 will be determined from plasma samples collected from all patients dosed with L-DOS47
5. Area under the concentration (AUC) vs time curve of L-DOS47 after dosing in combination treatment with pemetrexed/carboplatin
[ Time Frame: Up to 12 weeks ]

Pharmacokinetic parameters for L-DOS47 will be determined from plasma samples collected from all patients dosed with L-DOS47
6. Terminal elimination half-life of L-DOS47 after dosing in combination treatment with pemetrexed/carboplatin
[ Time Frame: Up to 12 weeks ]

Pharmacokinetic parameters for L-DOS47 will be determined from plasma samples collected from all patients dosed with L-DOS47
7. The presence of anti-L-DOS47 antibodies for patients dosed with L-DOS47 in combination treatment with pemetrexed/carboplatin
[ Time Frame: Up to 12 weeks ]

Serum samples will be collected and analyzed from all patients dosed with L-DOS47
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Helix BioPharma corporate website
Available IPD/Information:

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