18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/CarboplatinPrimary· Up to 12 weeks
Beginning with the start of study treatment at Cycle 1 Day 1 up to the last study visit: An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. Beginning with the AE reporting p
Treatment emergent AEs
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
3
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
6
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
2
Treatment emergent AEs related to L-DOS47
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
2
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
5
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
Treatment emergent SAEs
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
3
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
1
Treatment emergent SAEs related to L-DOS47
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
Number of Participants With Dose Limited Toxicities (DLTs) Related to L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin.Primary· Up to 21 days
A DLT was defined as the occurrence of any of the following events (according to NCI CTCAE version 4.0) that are considered to be (possibly/probably/definitely) related to L-DOS47 and occurring within 21 days after commencing study treatment:
* Haematological adverse events ≥ grade 4
* Non-haematological adverse events ≥ grade 3
* One instance each of any two unique grade 2 adverse events
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
Maximum Tolerated Dose of L-DOS47 in Combination With Pemetrexed/CarboplatinPrimary· 21 days
Defined as the highest dose level at which ≤ 1 of 6 patients experiences a dose limiting toxicity (DLT) as assessed during the first treatment cycle. If no DLT are reported, it is assumed that the maximum tolerated dose of L-DOS47 in combination with pemetrexed/carboplatin was not reached.
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
Objective Response Rate of Patients Receiving the Combination Treatment According to RECIST 1.1Secondary· 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; where complete response (CR) is the disappearance of all target lesions and partial response (PR) is at least a 30% reduction in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Partial response
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
3
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
Stable disease
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
2
Progressive disease
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
2
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
Percentage of Patients Receiving a Sustained Clinical BenefitSecondary· Up to 12 weeks
Defined as the percentage of patients who have achieved complete response, partial response, or stable disease following combination treatment with L-DOS47 + pemetrexed/carboplatin; where complete response (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% reduction in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and stable disease (SD) is where neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD, at least 20% increase in the sum of diameters of target lesi
Group
Value
95% CI
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
4
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
1
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
0
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
Serious: 0/3 (0%)
Deaths: 3/3
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
Serious: 3/6 (50%)
Deaths: 2/6
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
Serious: 0/1 (0%)
Deaths: 0/1
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
Serious: 1/1 (100%)
Deaths: 1/1
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
Serious: 1/1 (100%)
Deaths: 1/1
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
Serious: 1/2 (50%)
Deaths: 1/2
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Helix BioPharma Corporation
Last refreshed: 3 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02309892.