Lung AdenocarcinomaPhase 2NCT03891173
A Study of L-DOS47 in Combination With Vinorelbine/Cisplatin in Lung Adenocarcinoma
A Phase 2 study testing L-DOS47, Cisplatin and Vinorelbine in people with Lung Adenocarcinoma, run by Helix BioPharma Corporation at 4 sites in 2 countries.
Trial summary
This study will determine the highest dose of L-DOS47 that can be given in combination with vinorelbine/cisplatin, evaluate safety and tolerability of L-DOS47 when given in combination with vinorelbine/cisplatin, and assess how effective this combination is in treating patients with lung adenocarcinoma compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- L-DOS47, Cisplatin and Vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 19 Feb 2019to 22 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male or female aged ≥ 18 years old
- Histologically confirmed lung adenocarcinoma, classified as:
- Chemotherapy-naive patients with metastatic lung adenocarcinoma for whom vinorelbine/cisplatin would be appropriate therapy;
- metastatic recurrent lung adenocarcinoma following prior surgery, radiation and/or adjuvant chemotherapy at least 6 months ago, for whom vinorelbine/cisplatin would be appropriate therapy;
- Staging assessed according to Tumor Node Metastases (TNM), 8th edition and based on computed tomography (CT) scan;
- Grade 1 - 4 adenocarcinoma
Show all 20Show fewer
- No prior adjuvant chemotherapy within 6 months of the first treatment day if there is recurrent disease
- At least a single measurable lesion in accordance with the RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
- A life expectancy of ≥ 3 months
- Adequate organ function as determined by the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
- Platelet count ≥ 100 × 10^9/L
- Haemoglobin (HGB) ≥ 9 g/dL
- Creatinine clearance ≥ 60 mL/min calculated using the Cockcroft-Gault Formula and serum creatinine ≤ 1.5 × the upper limit of normal (ULN)
- Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 × ULN or < 5 × ULN if liver abnormalities are due to underlying malignancy
- Total bilirubin ≤ 1.5 × ULN Note: Blood transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of L-DOS47 is administered are not allowed.
- Able to understand the information provided to them and to give written informed consent before any study activities are conducted
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- Not pregnant and do not plan to become pregnant during the study. Females of childbearing potential must provide a negative pregnancy test within the Screening period (Day 21 to 0) and agree to use adequate non-hormonal contraception (which includes but is not limited to double barrier or sexual abstinence) during the study and for a period of 90 days following the last dose of study treatment. Male patients and their female partners of child-bearing potential must agree to each use an approved form of contraception during the study and for a period of 90 days following the last dose of study treatment.
Who cannot join
- Pregnant or nursing mother
- Prior history of other malignancies with the exception of non melanoma skin cancer
- Patients with a known positive Epidermal Growth Factor Receptor (EGFR) mutation or whose tumour harbour an anaplastic lymphoma kinase (ALK) translocation
- Active central nervous system metastasis and/or leptomeningeal disease (known or suspected); Patients with asymptomatic brain metastases are eligible if they had local therapy more than 1 month before enrolment
- Evidence of active infection
- Received treatment in another clinical study within the 30 days before commencing study drug and have not recovered from side effects of a study drug, except for alopecia
Show all 14Show fewer
- A serious uncontrolled medical condition
- Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive
- Sustained QT interval corrected for heart rate (QTc) with Fridericia's correction > 450 msec at Screening, or a history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of long QT syndrome)
- Pre-existing peripheral neuropathy Grade ≥ 1 CTCAE
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol
- Receiving chemotherapy during the 30 days before study treatment start; are receiving radiotherapy, targeted therapy, hormonal therapy, immunotherapy, major surgery or other study drugs during the 4 weeks before study treatment start, or have not recovered from all treatment related toxicities to Grade ≤ 1, except for alopecia. (Radiotherapy is allowed for the symptomatic treatment of bone metastases.)
- Taking systemic steroids (other than inhalers or topical steroids) or other medication to suppress the immune system
- Participating (or planning to participate) in any other clinical trial during this study
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Ukraine3 sites
Dnipropetrovsk City Multi-field Clinical Hospital #4
Dnipro, 49102
Sumy Regional Clinical Oncological Centre
Sumy, 40005
Vinnytsya Regional Clinical Oncological Centre
Vinnytsia, 21029
About this study
Official title: A Phase II, Open-Label, Randomized Study Immunoconjugate L-DOS47 in Combination With Vinorelbine/Cisplatin Versus Vinorelbine/Cisplatin Alone in Patients With Lung Adenocarcinoma
This study will determine the highest dose of L-DOS47 that can be given in combination with vinorelbine/cisplatin, evaluate safety and tolerability of L-DOS47 when given in combination with vinorelbine/cisplatin, and assess how effective this combination is in treating patients with lung adenocarcinoma compared to patients who are given vinorelbine/cisplatin alone.
Read the detailed description
The study is divided into two parts. In part I, the maximum tolerated dose of L-DOS47, when given in combination with vinorelbine/cisplatin, will be determined. Cohorts of 3 patients will be recruited into three dosing cohorts (6, 9 and 12 µg/kg). All patients at a given dose level must complete the first treatment cycle (3 week period) before escalation in subsequent patients can proceed. The decision for escalation to the next dose level will be made after the safety data have been reviewed by the Trial Steering Committee (TSC). If a patient in any cohort experiences a dose limiting toxicity, an additional 3 patients will be enrolled, for a maximum of up to 18 patients in this initial dose escalation part of the study.
In part II, after the maximum tolerated dose of L-DOS47 in combination with vinorelbine/cisplatin has been determined, a further 118 patients will be randomized (1:1) to receive L-DOS47 in combination with vinorelbine/cisplatin, or vinorelbine/cisplatin alone. Efficacy will be assessed by time to progression (time from first day of study drug administration to documented disease progression), response rate (proportion of patients with a best overall response of complete response and partial response using the Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1 criteria), and overall survival (time from first day of study drug administration to death due to any cause). Monitoring will include radiological evaluations every second cycle. Safety and tolerability of L-DOS47 in combination will also continue to be evaluated.
For all patients, treatment will continue either until the patient experiences disease progression, unacceptable toxicity, the patient withdraws consent or has completed four treatment cycles.
- Conditions
- Lung Adenocarcinoma
- Being tested
- L-DOS47, Cisplatin, Vinorelbine
- Keywords
- lung adenocarcinoma, immunoconjugate, tumor microenvironment alkalinization
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-DOS47Drug
L-DOS47 lyophilized powder reconstituted and diluted for iv injection
CisplatinDrug
Cisplatin concentrate for solution for iv infusion
VinorelbineDrug
Also called vinorelbine tartrate
Vinorelbine concentrate for solution for iv infusion
| Study group | Role | What they receive |
|---|---|---|
| L-DOS47 in combination with cisplatin + vinorelbine | Experimental | L-DOS47 (6/9/12 µg/kg) is administered by iv on Day 1 and 8 of each 21-day treatment cycle, in combination with iv administration of standard cisplatin (80 mg/m2) on Day 2 + vinorelbine (30 mg/m2) on Day 2 and 9. Receives: Drug: L-DOS47; Drug: Cisplatin; Drug: Vinorelbine |
| Cisplatin + vinorelbine alone | Active comparator | Administration by iv of standard Cisplatin (80 mg/m2) on Day 1 + vinorelbine (30 mg/m2) on Day 1 and 8 of each 21-day treatment cycle. Receives: Drug: Cisplatin; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression
Time from first day of study drug administration to documentation of disease progression (including death due to progression)
Measured: Up to 12 weeks
Secondary outcomes (3)
Objective response rate as measured using RECIST v. 1.1
Proportion of patients with a best overall response of complete response and partial response
Measured: Up to 12 weeks
Overall survival
Time to death as defined as time from first day of study drug administration to death to to any cause
Measured: Up to 12 weeks
Safety and tolerability of L-DOS47 in combination with vinorelbine/cisplatin: Frequency of treatment emergence adverse events in patients
Frequency of treatment emergent adverse events in patients
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.
- First posted26 Mar 2019
- Study start19 Feb 2019
- Primary completion22 May 2020
- Study completion22 May 2020
Why it stopped: Study was halted at this time due to other budgetary priorities. Completion of reporting has been delayed first due to covid restrictions and more recently due to war in Ukraine.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part I includes a brief initial dose escalation phase, followed by Part II, which includes a randomized treatment phase.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helix BioPharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCR S.A.
- Responsible party
- Sponsor
- Investigators
- Cezary Szczylik, MD, Ph.D., Principal investigator, Europejskie Centrum Zdrowia Otwock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891173
- Sponsor's protocol ID
- LDOS003
- Other IDs
- 2016-003015-34, 2016
- Status last verified
- Aug 2022
- First submitted
- 18 Mar 2019
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Randomized Study Immunoconjugate L-DOS47 in Combination With Vinorelbine/Cisplatin Versus Vinorelbine/Cisplatin Alone in Patients With Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03891173
- Acronym / sponsor ID
- LDOS003
- Conditions
- Lung Adenocarcinoma
- Keywords
- lung adenocarcinoma, immunoconjugate, tumor microenvironment alkalinization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was halted at this time due to other budgetary priorities. Completion of reporting has been delayed first due to covid restrictions and more recently due to war in Ukraine.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Helix BioPharma CorporationIndustry (pharma, biotech, devices)
- Collaborators
- KCR S.A.
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the highest dose of L-DOS47 that can be given in combination with vinorelbine/cisplatin, evaluate safety and tolerability of L-DOS47 when given in combination with vinorelbine/cisplatin, and assess how effective this combination is in treating patients with lung adenocarcinoma compared to patients who are given vinorelbine/cisplatin alone.
Detailed description
The study is divided into two parts. In part I, the maximum tolerated dose of L-DOS47, when given in combination with vinorelbine/cisplatin, will be determined. Cohorts of 3 patients will be recruited into three dosing cohorts (6, 9 and 12 µg/kg). All patients at a given dose level must complete the first treatment cycle (3 week period) before escalation in subsequent patients can proceed. The decision for escalation to the next dose level will be made after the safety data have been reviewed by the Trial Steering Committee (TSC). If a patient in any cohort experiences a dose limiting toxicity, an additional 3 patients will be enrolled, for a maximum of up to 18 patients in this initial dose escalation part of the study.
In part II, after the maximum tolerated dose of L-DOS47 in combination with vinorelbine/cisplatin has been determined, a further 118 patients will be randomized (1:1) to receive L-DOS47 in combination with vinorelbine/cisplatin, or vinorelbine/cisplatin alone. Efficacy will be assessed by time to progression (time from first day of study drug administration to documented disease progression), response rate (proportion of patients with a best overall response of complete response and partial response using the Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1 criteria), and overall survival (time from first day of study drug administration to death due to any cause). Monitoring will include radiological evaluations every second cycle. Safety and tolerability of L-DOS47 in combination will also continue to be evaluated.
For all patients, treatment will continue either until the patient experiences disease progression, unacceptable toxicity, the patient withdraws consent or has completed four treatment cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part I includes a brief initial dose escalation phase, followed by Part II, which includes a randomized treatment phase.
| Arm | Type | Receives |
|---|---|---|
| L-DOS47 in combination with cisplatin + vinorelbine | Experimental | Drug: L-DOS47, Drug: Cisplatin, Drug: VinorelbineL-DOS47 (6/9/12 µg/kg) is administered by iv on Day 1 and 8 of each 21-day treatment cycle, in combination with iv administration of standard cisplatin (80 mg/m2) on Day 2 + vinorelbine (30 mg/m2) on Day 2 and 9. |
| Cisplatin + vinorelbine alone | Active comparator | Drug: Cisplatin, Drug: VinorelbineAdministration by iv of standard Cisplatin (80 mg/m2) on Day 1 + vinorelbine (30 mg/m2) on Day 1 and 8 of each 21-day treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female aged ≥ 18 years old
- Histologically confirmed lung adenocarcinoma, classified as:
- No prior adjuvant chemotherapy within 6 months of the first treatment day if there is recurrent disease
- At least a single measurable lesion in accordance with the RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
Key exclusion criteria (14 listed)
- Pregnant or nursing mother
- Prior history of other malignancies with the exception of non melanoma skin cancer
- Patients with a known positive Epidermal Growth Factor Receptor (EGFR) mutation or whose tumour harbour an anaplastic lymphoma kinase (ALK) translocation
- Active central nervous system metastasis and/or leptomeningeal disease (known or suspected); Patients with asymptomatic brain metastases are eligible if they had local therapy more than 1 month before enrolment
- Evidence of active infection
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-DOS47L-DOS47 lyophilized powder reconstituted and diluted for iv injection | Drug | L-DOS47 in combination with cisplatin + vinorelbine |
| CisplatinCisplatin concentrate for solution for iv infusion | Drug | Cisplatin + vinorelbine alone, L-DOS47 in combination with cisplatin + vinorelbine |
| VinorelbineAlso: vinorelbine tartrateVinorelbine concentrate for solution for iv infusion | Drug | Cisplatin + vinorelbine alone, L-DOS47 in combination with cisplatin + vinorelbine |
Primary outcome
Time to disease progression
Time frame: Up to 12 weeks
Time from first day of study drug administration to documentation of disease progression (including death due to progression)
3 secondary outcomes
Objective response rate as measured using RECIST v. 1.1
Time frame: Up to 12 weeks
Overall survival
Time frame: Up to 12 weeks
Safety and tolerability of L-DOS47 in combination with vinorelbine/cisplatin: Frequency of treatment emergence adverse events in patients
Time frame: Up to 12 weeks
Results and safety
The study was stopped early (reason given: Study was halted at this time due to other budgetary priorities. Completion of reporting has been delayed first due to covid restrictions and more recently due to war in Ukraine.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Lung Adenocarcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Cezary Szczylik, MD, Ph.D. principal investigator
Europejskie Centrum Zdrowia Otwock
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-DOS47, Cisplatin and Vinorelbine in people with Lung Adenocarcinoma, run by Helix BioPharma Corporation at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. 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 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ukraine, Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was halted at this time due to other budgetary priorities. Completion of reporting has been delayed first due to covid restrictions and more recently due to war in Ukraine.). Results are not available in the source record.
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?
Time to disease progression (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2022.