A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
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ClinicalTrials.gov Identifier: NCT02309892 |
Recruitment Status :
Completed
First Posted : December 5, 2014
Last Update Posted : February 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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Non-Small Cell Lung Cancer | Drug: L-DOS47 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | August 2019 |
Actual Study Completion Date : | September 2019 |

Arm | Intervention/treatment |
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Experimental: Pemetrexed and Carboplatin plus L-DOS47
Patients will be recruited into cohorts of L DOS47 escalating doses, with a minimum of 3 and a maximum of 6 patients per cohort. The starting dose of L DOS47 will be 0.59 µg/kg; further possible dose levels that may be assessed are 0.78, 1.04, 1.38 and 1.84 µg/kg. The standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], respectively, to be administered in combination with L-DOS47, will remain constant across cohorts.
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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. |
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Main 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
Main Exclusion Criteria:
- Histologic evidence of predominantly squamous cell NSCLC
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309892
United States, Ohio | |
University Hospitals Case Medical Center | |
Cleveland, Ohio, United States | |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States |
Responsible Party: | Helix BioPharma Corporation |
ClinicalTrials.gov Identifier: | NCT02309892 |
Other Study ID Numbers: |
LDOS001 |
First Posted: | December 5, 2014 Key Record Dates |
Last Update Posted: | February 24, 2020 |
Last Verified: | February 2020 |
Non-Small Cell Lung Cancer Neoplasms Immunoconjugate Tumor microenvironment alkalinization |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |