Non-Small Cell Lung CancerPhase 1NCT02309892

A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC

A Phase 1 study testing L-DOS47 in people with Non-Small Cell Lung Cancer, run by Helix BioPharma Corporation at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: L-DOS47
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 2 sitesUnited States
Study dates: 20 Apr 2015to 20 Sep 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University Hospitals Case Medical Center
Cleveland, Ohio
The University of Texas MD Anderson Cancer Center
Houston, Texas

Other trials in United States

About this study

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

Read the 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.

Conditions: Non-Small Cell Lung Cancer
Being tested: L-DOS47
Keywords: Non-Small Cell Lung Cancer, Neoplasms, Immunoconjugate, Tumor microenvironment alkalinization
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L-DOS47Drug
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.

Study groups in NCT02309892
Study group	Role	What they receive
Pemetrexed and Carboplatin plus L-DOS47	Experimental	Patients will be recruited into cohorts of L-DOS47 escalating doses, with a minimum of 3 and a maximum of 6 patients per cohort for the first and last two dosing cohorts, and a minimum of 1 and a maximum of 2 patients for the middle three dosing cohorts. The starting dose of L-DOS47 will be 0.59 µg/kg; further planned dose levels to be assessed are 0.78, 1.5, 3.0, 6.0, 9.0 and 12.0 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. Receives: Drug: L-DOS47

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin
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 period at the start of study treatment at Cycle 1 Day 1 up to the last study visit;
Measured: Up to 12 weeks
Number of Participants With Dose Limited Toxicities (DLTs) Related to L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin.
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
Measured: Up to 21 days
Maximum Tolerated Dose of L-DOS47 in Combination With Pemetrexed/Carboplatin
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.
Measured: 21 days

Secondary outcomes (2)

Objective Response Rate of Patients Receiving the Combination Treatment According to RECIST 1.1
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.
Measured: Up to 12 weeks
Percentage of Patients Receiving a Sustained Clinical Benefit
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 lesions, taking as reference the smallest sum on study).
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201520 Sep 2019

First posted5 Dec 2014 (estimated)
Study start20 Apr 2015
Primary completion19 Aug 2019
Study completion20 Sep 2019

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: Single arm, dose escalation where patients are recruited into cohorts of escalating doses of L-DOS47 (0.59 up to 12.0 µg/kg) in combination with pemetrexed and carboplatin.
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02309892
Sponsor's protocol ID: LDOS001
Status last verified: Dec 2023
First submitted: 9 Apr 2013
Last updated: 3 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02309892
Acronym / sponsor ID: LDOS001
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer, Neoplasms, Immunoconjugate, Tumor microenvironment alkalinization
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 14 participants (actual)
Lead sponsor: Helix BioPharma CorporationIndustry (pharma, biotech, devices)
Collaborators: Theradex
Study start: 20 Apr 2015 (actual)
Primary completion: 19 Aug 2019 (actual)
Study completion: 20 Sep 2019 (actual)
First posted: 5 Dec 2014 (estimated)
Results: Posted 3 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: Single arm, dose escalation where patients are recruited into cohorts of escalating doses of L-DOS47 (0.59 up to 12.0 µg/kg) in combination with pemetrexed and carboplatin.

Arm	Type	Receives
Pemetrexed and Carboplatin plus L-DOS47	Experimental	Drug: L-DOS47Patients will be recruited into cohorts of L-DOS47 escalating doses, with a minimum of 3 and a maximum of 6 patients per cohort for the first and last two dosing cohorts, and a minimum of 1 and a maximum of 2 patients for the middle three dosing cohorts. The starting dose of L-DOS47 will be 0.59 µg/kg; further planned dose levels to be assessed are 0.78, 1.5, 3.0, 6.0, 9.0 and 12.0 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
L-DOS47A 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.	Drug	Pemetrexed and Carboplatin plus L-DOS47

Primary outcome

Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin
Time frame: 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 period at the start of study treatment at Cycle 1 Day 1 up to the last study visit;
Number of Participants With Dose Limited Toxicities (DLTs) Related to L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin.
Time frame: 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
Maximum Tolerated Dose of L-DOS47 in Combination With Pemetrexed/Carboplatin
Time frame: 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.

2 secondary outcomes

Objective Response Rate of Patients Receiving the Combination Treatment According to RECIST 1.1
Time frame: Up to 12 weeks
Percentage of Patients Receiving a Sustained Clinical Benefit
Time frame: Up to 12 weeks

Results and safety

Results posted to the registry on 3 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin	3	1
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin	6	5
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin	1	0
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin	1	1
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin	1	0
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin	2	1
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin	0	0

Primary outcome: Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin

Time frame: Up to 12 weeks. Count of participants. Unit: Participants

Measure	L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin n = 3	L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin n = 6	L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin n = 1	L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 1	L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 1	L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 2	L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 0
Treatment emergent AEs	3	6	1	1	1	2	–
Treatment emergent AEs related to L-DOS47	2	5	0	0	0	0	–
Treatment emergent SAEs	0	3	0	1	1	1	–
Treatment emergent SAEs related to L-DOS47	0	0	0	0	0	0	–

Population analysed: Any subject who has received any amount of study treatment.

Primary outcome: Number of Participants With Dose Limited Toxicities (DLTs) Related to L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin.

Time frame: Up to 21 days. Count of participants. Unit: Participants

Measure	L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin n = 3	L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin n = 6	L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin n = 1	L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 1	L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 1	L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 2	L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 0
Value	0	0	0	0	0	0	–

Population analysed: Any subject who has received all scheduled doses of L-DOS47 in Cycle 1; a DLT is assumed to have occurred if a patient does not receive all scheduled doses of L-DOS47 due to toxicity

Primary outcome: Maximum Tolerated Dose of L-DOS47 in Combination With Pemetrexed/Carboplatin

Time frame: 21 days. Count of participants. Unit: Participants

Measure	L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin n = 3	L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin n = 6	L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin n = 1	L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 1	L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 1	L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 2	L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin n = 0
Value	0	0	0	0	0	0	–

Population analysed: Any subject who experienced a dose-limiting toxicity (DLT); a DLT is also assumed to have occurred if a patient does not receive all scheduled doses of L-DOS47 due to toxicity

2 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin	0 of 3 (0%)	3 of 3 (100%)	3 of 3
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin	3 of 6 (50%)	6 of 6 (100%)	2 of 6
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin	0 of 1 (0%)	1 of 1 (100%)	0 of 1
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin	1 of 1 (100%)	1 of 1 (100%)	1 of 1
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin	1 of 1 (100%)	1 of 1 (100%)	1 of 1
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin	1 of 2 (50%)	2 of 2 (100%)	1 of 2
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Patient enrolment was halted at cohort 6 (9.0 ug/kg) due to slow recruitment and therefore, the seventh and highest dosing cohort (12 ug/kg) could not be completed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Helix BioPharma corporate websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing L-DOS47 in people with Non-Small Cell Lung Cancer, run by Helix BioPharma Corporation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin (time frame: Up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02309892.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.