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CompletedNCT03743064Updated Jun 26, 2024Results posted

A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 interventional study of anamorelin HCl and Placebo Oral Tablet in Cachexia; Cancer and Non Small Cell Lung Cancer, sponsored by Helsinn Healthcare SA. Completed at 65 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Helsinn Healthcare SA · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia (cancer-related weight loss). The main question it aimed to answer was as follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anorexia symptoms than those who receive placebo.

Approximately 316 patients were to be enrolled in the study. Of these patients, an equal number were to be assigned to each treatment group (anamorelin HCl or placebo). Participants were to take their assigned study drug by mouth once daily for a total of 24 weeks. During this treatment period, the patients were to visit the clinical study site every 3 weeks for health and other study-related assessments. Two weeks after the last treatment, patients were to receive a follow-up phone call.

Read the detailed description

The study was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. It was planned that approximately 316 patients with advanced NSCLC with cachexia were to be randomized 1:1 to anamorelin HCl 100 mg or placebo (158 patients per treatment group). The study treatment was to be taken orally once daily for a total of 24 weeks. Patients were instructed to take the study drug at least 1 hour before their first meal of the day.

Central randomization was stratified by line of systemic anti-cancer treatment (first line vs second line vs third line or higher), by type of anti-cancer therapy (immunotherapy vs non-immunotherapy), and by baseline score of 5 IASS (≤10 vs >10). Patients who had never received anti-cancer treatment prior to entering the study but who met all eligibility criteria were eligible to enter the study and were assigned to receive first line treatment in the Interactive Web Response System (IWRS).

Patients were to visit the site every 3 weeks for the study Treatment Period of 24 weeks. A follow-up telephone visit was to be scheduled at Week 26. Thus, patients were enrolled in the study for a maximum duration of 27 weeks (including a 1-week Screening Period, a 24-week Treatment Period, and a 2-week Follow-up Period). Each patient was scheduled to have a total of 10 planned visits plus 1 telephone contact for the Follow-up Visit.

02

Conditions studied

  • Cachexia; Cancer
  • Non Small Cell Lung Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed written informed consent
  2. Female or male ≥18 years of age
  3. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) Stage III or IV NSCLC. Stage III patient must have unresectable disease
  4. Body mass index \< 20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening
  5. Ongoing problems with appetite/eating associated with the underlying cancer, as determined by having score of ≤ 17 points on the 5-item Anorexia Symptom Scale and ≤ 37 points on the 12-item FAACT A/CS

  6. Patient receiving or not receiving systemic anti-cancer treatment at the time of screening are eligible to participate. Systemic anti-cancer treatment includes first, second, third treatment line with chemotherapy/radiation therapy, immunotherapy or targeted therapy.

    Patient not receiving systemic anti-cancer treatment is eligible if:

    1. Not planning to receive anti-cancer treatment and/or at least 14 days must be elapsed from the completion of prior treatment at the day of screening, in case underwent previous cycle OR
    2. Planning to receive anti-cancer treatment within 14 days from randomization and/or at least 14 days must be elapsed from the completion of prior treatment at the day of screening, in case underwent previous cycle OR
    3. Patient on palliative care treatment
  7. ECOG performance status 0,1 or 2 at screening
  8. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN or if hepatic metastases are present ≤ 5 x ULN
  9. Adequate renal function, defined as creatinine ≤2 ULN, or calculated creatinine clearance >30 ml/minute

  10. Female patient shall be: a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test within 24 hours prior to first dose of investigational product.

    Notes:

    1. Female patient of non-childbearing potential are defined as being in post-menopausal state since at least 1 year; or having documented surgical sterilization or hysterectomy at least 3 months before study participation.
    2. Reliable contraceptive measures include implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized partner or complete (long term) sexual abstinence.
  11. The patient must be willing and able to comply with the protocol tests and procedures All inclusion criteria will be checked at screening visit (Visit 1).

Exclusion criteria

Exclusion Criteria:

  1. Patient with other forms of lung cancer (e.g., small cell, neuroendocrine tumors)
  2. Woman who is pregnant or breast-feeding

  3. Reversible causes of reduced food intake, as determined by the Investigator. These causes may include but are not limited to:

    1. NCI CTCAE Grade 3 or 4 oral mucositis,
    2. NCI CTCAE Grade 3 or 4 GI disorders [nausea, vomiting, diarrhea, and constipation],
    3. mechanical obstructions making patient unable to eat, or
    4. severe depression
  4. Patient undergoing major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patient must be well recovered from acute effects of surgery prior to screening. Patient should not have plans to undergo major surgical procedures during the treatment period
  5. Patient currently taking androgenic compounds (including but not limited to testosterone, testosterone-like agents, oxandrolone, megestrol acetate, corticosteroids, olanzapine, mirtazapine (however, long-term use of mirtazapine for depression for at least four weeks prior to screening is allowed), dronabinol or marijuana (cannabis) or any other prescription medication or off-label products intended to increase appetite or treat unintentional weight loss
  6. Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring drainage, edema or evidence of ascites

  7. Patient with uncontrolled or significant cardiovascular disease, including:

    1. History of myocardial infarction within the past 3 months
    2. A-V block of second or third degree (may be eligible if currently have a pacemaker)
    3. Unstable angina
    4. Congestive heart failure within the past 3 months, if defined as NYHA class III-IV
    5. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)
    6. Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic)
    7. Heart rate \< 50 beats per minute on pre-entry electrocardiogram and patient is symptomatic
  8. Patient on drugs that may prolong the PR or QRS interval durations, such as any of the antiarrhythmic medications Class I (Fast sodium (Na) channel blockers)
  9. Patient unable to readily swallow oral tablets
  10. Patient with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption)
  11. Patient with history of gastrectomy
  12. Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus

  13. Patient with cachexia caused by other reasons, as determined by the investigator such as:

    1. Severe COPD requiring use of home O2,
    2. New York Heart Association (NYHA) class III-IV heart failure
    3. AIDS
    4. Uncontrolled thyroid disease
  14. Patient receiving strong CYP3A4 inhibitors within 14 days of randomization
  15. Patient currently receiving tube feedings or parenteral nutrition (either total or partial).
  16. Current excessive alcohol or illicit drug use
  17. Any condition, including the presence of laboratory abnormalities, which in the Investigator's opinion, places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  18. Enrollment in a previous study with anamorelin HCl
  19. Patient actively receiving a concurrent investigational agent, or having received an investigational agent within 28 days of Day 1 All exclusion criteria will be checked at screening visit (Visit 1).
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
318 participants (actual)

Study arms

  • Experimental
    100 mg anamorelin HCl

    100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks

    Drug: anamorelin HCl

  • Placebo comparator
    Placebo

    Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks

    Drug: Placebo Oral Tablet

Interventions

  • Druganamorelin HCl

    100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)

  • DrugPlacebo Oral Tablet

    Placebo (administered as matching placebo tablets in the fasted condition)

05

What researchers measure

Primary outcomes

  1. Mean Change From Baseline in Body Weight Over 12 Weeks

    This co-primary efficacy endpoint was mean change from baseline in body weight (kg) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.

    Time frame: Mean change from baseline over 12 weeks.

  2. Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks

    This co-primary efficacy endpoint was mean change from baseline in 5-IASS (points) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment. FAACT-A/CS (Functional Assessment Anorexia Cachexia Therapy) is a 12-item measure of patients' perceptions of anorexia/cachexia symptoms and concerns. From this questionnaire, the 5-item section referring to anorexia symptoms (i.e., "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods") was used to assess 5-IASS. The range of possible scores is 0-20. Higher scores indicate lower levels of symptom burden.

    Time frame: Mean change from baseline over 12 weeks.

Secondary outcomes

  1. Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)

    The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥0 kg.

    Time frame: Duration of treatment benefit from baseline over 12 weeks.

  2. Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg)

    The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥1.5 kg.

    Time frame: Duration of treatment benefit from baseline over 12 weeks.

  3. Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points)

    The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥0 points.

    Time frame: Duration of treatment benefit from baseline over 12 weeks.

  4. Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points)

    The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥3 points.

    Time frame: Duration of treatment benefit from baseline over 12 weeks.

06

Results

Posted Jun 26, 2024

Participant flow

Patients were enrolled at a total of 49 study sites in Australia (2 sites), Belgium (2 sites), Croatia (3 sites), Germany (3 sites), Poland (5 sites), Romania (7 sites), Russia (10 sites), Ukraine (8 sites), and USA (9 sites). First Patient Enrollment (date of randomization) was on 06MAY2019.

Participant flow — Overall Study
Milestone100 mg Anamorelin HClPlacebo
Started154164
Treated154164
Completed8390
Not completed7174
Withdrew: Adverse event79
Withdrew: Death2528
Withdrew: Lost to follow-up36
Withdrew: Withdrawal by subject2825
Withdrew: Physician decision24
Withdrew: Reported as "other" in clinical study report62

Outcome measures

PrimaryMean Change From Baseline in Body Weight Over 12 Weeks

This co-primary efficacy endpoint was mean change from baseline in body weight (kg) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.

Time frame:
Mean change from baseline over 12 weeks.
Reported as:
Least squares mean · kg
Mean Change From Baseline in Body Weight Over 12 Weeks
kg100 mg Anamorelin HClPlacebo
Mean Change From Baseline in Body Weight Over 12 Weeks1.822 ± 0.2630.538 ± 0.250
Statistical analysis
  • 100 mg Anamorelin HCl vs Placebo · ANOVA · p = <0.0001 · Mean difference (final values): 1.284 · 95% CI 0.718 to 1.851
PrimaryMean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks

This co-primary efficacy endpoint was mean change from baseline in 5-IASS (points) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment. FAACT-A/CS (Functional Assessment Anorexia Cachexia Therapy) is a 12-item measure of patients' perceptions of anorexia/cachexia symptoms and concerns. From this questionnaire, the 5-item section referring to anorexia symptoms (i.e., "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods") was used to assess 5-IASS. The range of possible scores is 0-20. Higher scores indicate lower levels of symptom burden.

Time frame:
Mean change from baseline over 12 weeks.
Reported as:
Least squares mean · score on a scale
Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks
score on a scale100 mg Anamorelin HClPlacebo
Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks3.432 ± 0.3603.291 ± 0.342
Statistical analysis
  • 100 mg Anamorelin HCl vs Placebo · ANOVA · p = 0.7241 · Mean difference (final values): 0.141 · 95% CI -0.641 to 0.923
SecondaryDuration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥0 kg.

Time frame:
Duration of treatment benefit from baseline over 12 weeks.
Reported as:
Least squares mean · weeks
Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)
weeks100 mg Anamorelin HClPlacebo
Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)8.859 ± 0.5256.778 ± 0.496
Statistical analysis
  • 100 mg Anamorelin HCl vs Placebo · ANOVA · p = 0.0003 · Mean difference (final values): 2.081 · 95% CI 0.946 to 3.216
SecondaryDuration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg)

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥1.5 kg.

Time frame:
Duration of treatment benefit from baseline over 12 weeks.
Reported as:
Least squares mean · weeks
Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg)
weeks100 mg Anamorelin HClPlacebo
Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg)5.490 ± 0.4313.087 ± 0.409
Statistical analysis
  • 100 mg Anamorelin HCl vs Placebo · ANOVA · p = <0.0001 · Mean difference (final values): 2.404 · 95% CI 1.471 to 3.337
SecondaryDuration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points)

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥0 points.

Time frame:
Duration of treatment benefit from baseline over 12 weeks.
Reported as:
Least squares mean · weeks
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points)
weeks100 mg Anamorelin HClPlacebo
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points)9.470 ± 0.3928.842 ± 0.370
Statistical analysis
  • 100 mg Anamorelin HCl vs Placebo · ANOVA · p = 0.1443 · Mean difference (final values): 0.629 · 95% CI -0.215 to 1.472
SecondaryDuration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points)

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥3 points.

Time frame:
Duration of treatment benefit from baseline over 12 weeks.
Reported as:
Least squares mean · weeks
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points)
weeks100 mg Anamorelin HClPlacebo
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points)5.143 ± 0.4104.992 ± 0.387
Statistical analysis
  • 100 mg Anamorelin HCl vs Placebo · ANOVA · p = 0.7376 · Mean difference (final values): 0.151 · 95% CI -0.734 to 1.036

Adverse events

Collected over Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
100 mg Anamorelin HCl25/154 (16.2%)44/154 (28.6%)114/154 (74%)
Placebo28/164 (17.1%)46/164 (28%)127/164 (77.4%)
Most frequent serious events
Showing 10 of 56
Most frequent serious events
Event100 mg Anamorelin HClPlacebo
Non-small cell lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)18/15419/164
AnaemiaBlood and lymphatic system disorders4/1543/164
Corona virus infectionInfections and infestations3/1542/164
PneumoniaInfections and infestations3/1543/164
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/1541/164
Cardiac disorderCardiac disorders2/1540/164
Pulmonary haemorrhageRespiratory, thoracic and mediastinal disorders0/1542/164
NeutropeniaBlood and lymphatic system disorders0/1542/164
Cancer painNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1540/164
Metastases to boneNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1540/164
Most frequent other events
Showing 10 of 38
Most frequent other events
Event100 mg Anamorelin HClPlacebo
AnaemiaBlood and lymphatic system disorders28/15438/164
AstheniaGeneral disorders19/15422/164
NauseaGastrointestinal disorders18/15412/164
Non-Small Cell Lung CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)10/15419/164
DyspnoeaRespiratory, thoracic and mediastinal disorders14/15410/164
Chest PainGeneral disorders13/1549/164
Sinus TachycardiaCardiac disorders7/15413/164
DizzinessNervous system disorders12/1545/164
DiarrhoeaGastrointestinal disorders10/1546/164
NeutropeniaBlood and lymphatic system disorders10/1546/164

Baseline characteristics

The Intent-to-Treat (ITT) Set included all randomized patients and was analyzed as per planned treatment.

Age, Continuous
Age, Continuous(Years)100 mg Anamorelin HClPlaceboTotal
Mean64.0 ± 8.4963.6 ± 9.7363.8 ± 9.14
Sex: Female, Male
Sex: Female, Male(Participants)100 mg Anamorelin HClPlaceboTotal
Female425092
Male112114226
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)100 mg Anamorelin HClPlaceboTotal
Hispanic or Latino011
Not Hispanic or Latino8715
Unknown or Not Reported146156302
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)100 mg Anamorelin HClPlaceboTotal
Asian448
Black or African American022
White148157305
Other011
Multiple202
Region of Enrollment
Region of Enrollment(Participants)100 mg Anamorelin HClPlaceboTotal
Romania5859117
Belgium235
United States8816
Ukraine383472
Poland111930
Australia134
Croatia5510
Russia272956
Germany448
Height
Height(cm)100 mg Anamorelin HClPlaceboTotal
Mean171.03 ± 8.690169.96 ± 9.164170.48 ± 8.940
Weight
Weight(kg)100 mg Anamorelin HClPlaceboTotal
Mean54.09 ± 7.02952.84 ± 7.92553.44 ± 7.519
Body Mass Index
Body Mass Index(kg/m^2)100 mg Anamorelin HClPlaceboTotal
Mean18.38 ± 1.32818.16 ± 1.57918.27 ± 1.465

5 further baseline measures are reported on the registry.

07

Study locations

65 sites
  • The University of Arizona Cancer Center - North Campus
    Tucson, Arizona 85719, United States
  • Pacific Cancer Medical Center, Inc
    Anaheim, California 92801, United States
  • CBCC Global Research Inc
    Bakersfield, California 93309, United States
  • Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
    Fountain Valley, California 92708, United States
  • Marin Cancer Care
    Greenbrae, California 94904, United States
  • Smilow Cancer Hospital at Yale-New Haven
    Waterbury, Connecticut 06708, United States
  • Bond & Steele Clinic P.A.
    Winter Haven, Florida 33881, United States
  • Presence Infusion Care
    Skokie, Illinois 60077, United States
  • Siouxland Regional Cancer Center dba June E.Nylen Cancer Center
    Sioux City, Iowa 51101, United States
  • Cancer Center of Kansas
    Wichita, Kansas 67214, United States
  • Cancer and Hematology Centers of Western Michigan
    Grand Rapids, Michigan 49503, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • New Jersey Hematology Oncology Associates Inc
    Brick, New Jersey 08724, United States
  • Hunterdon Hematology Oncology LLC
    Flemington, New Jersey 08822, United States
  • Hematology Oncology Center at Nyack Hospital
    Nyack, New York 10960, United States
  • University of Rochester, Medical Center
    Rochester, New York 14642, United States
  • Duke Cancer Center
    Durham, North Carolina 27710, United States
  • Toledo Clinic Cancer Center-Toledo
    Toledo, Ohio 43623, United States
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030-4009, United States
  • Calvary Central Districts Hospital
    Elizabeth Vale, South Australia 5112, Australia
  • Flinders Medical Centre
    Bedford Park, 5042, Australia
  • St Vincent's Hospital Melbourne
    Fitzroy, 3065, Australia
  • Barwon Health, The McKellar Centre
    North Geelong, 3215, Australia
  • The Royal Melbourne Hospital
    Parkville, 3050, Australia
  • Gold Coast University Hospital
    Southport, 4215, Australia
  • Jules Bordet Institut
    Brussels, 1000, Belgium
  • Saint Luc University Hospital
    Brussels, 1200, Belgium
  • Charleroi Grand Hospital (GHDC)
    Charleroi, 6000, Belgium
  • University Hospital Antwerp (UZA)
    Edegem, 2650, Belgium
  • General Hospital Delta
    Roeselare, 8800, Belgium
  • General Hospital Pula
    Pula, 52 100, Croatia
  • University Hospital Center Split
    Split, 21000, Croatia
  • University Hospital Center Zagreb
    Zagreb, 10000, Croatia
  • Wladyslaw Bieganski Regional Specialist Hospital, Clinical Oncology Department
    Grudziądz, 86-300, Poland
  • "VEGAMED" Non-Public Healthcare Facility
    Katowice, 40-060, Poland
  • MED - POLONIA Ltd.
    Poznań, 60-693, Poland
  • Specialist Hospital in Prabuty sp. z o.o. [limited liability company], Department of Pulmonology
    Prabuty, 82-550, Poland
  • Maria Skfodowska-Curie Institute of Oncology, Department of Lung and Thoracic Cancers
    Warsaw, 02-781, Poland
  • Mazovian Oncology Hospital, Oncology Outpatient Clinic
    Wieliszew, 05-135, Poland
  • MSF Institute Ltd. Santa Familia Medical Institute
    Łódź, 90-302, Poland
  • "Prof. Dr. Ion Chiricuta" Institute of Oncology, Medical Oncology Department
    Cluj-Napoca, Cluj County 400015, Romania
  • "Sf. Nectarie" Oncology Center, Medical Oncology Department
    Craiova, Dolj County 200347, Romania
  • SC Oncopremium Team SRL, Medical Oncology Department
    Baia Mare, Maramures 430291, Romania
  • Topmed Medical Center, Medical Oncology Department
    Târgu-Mureş, Murers 540156, Romania
  • Sf. Ioan cel Nou Country Emergency Hospital, Oncology Department
    Suceava, Suceava County 720237, Romania
  • S.C. Oncomed SRL, Medical Oncology Department
    Timisoara, Timis 300239, Romania
  • Alexandru Trestioreanu Institute of Oncology
    Bucharest, 022328, Romania
  • Republican Clinical Oncology Center
    Kazan, 420029, Russian Federation
  • Pyatigorsk Interdistric Oncology Center
    Pyatigorsk, 357502, Russian Federation
  • Oncology Center of Moskovskiy District
    Saint Petersburg, 196247, Russian Federation
  • AV Medical Group
    Saint Petersburg, 197082, Russian Federation
  • City Clinical Oncology Center
    Saint Petersburg, 198255, Russian Federation
  • Samara Regional Clinical Oncology Center
    Samara, 443031, Russian Federation
  • Ogaryov Mordovia National Research State University, Republican Oncology Center
    Saransk, 430032, Russian Federation
  • Oncology Center #2
    Sochi, 354057, Russian Federation
  • Palliative Care Center Devita
    St. Petersburg, 197183, Russian Federation
  • Volgograd Regional Clinical Oncology Center
    Volgograd, 400138, Russian Federation
  • Publ Non- Profit Ent. under Kharkiv Reg. Council
    Kharkiv, Kharkiev Region 61166, Ukraine
  • Communal Non-Profit Enterprise "Regional Center of Oncology"
    Kharkiv, Kharkiev 61070, Ukraine
  • Medical Center "VERUM" Limited Liability Company
    Kyiv, Kyviv 3039, Ukraine
  • Public Entreprise "Poltava Regional Clinical Oncology Center under Poltava Regional Council"
    Poltava, Poltava Region 36011, Ukraine
  • Medical Center "MEDICAL PLAZA" of the Limited Liability Company "EKODNIPRO"
    Dnipro, 49055, Ukraine
  • Private Enterprise "First Private Clinic"
    Kyiv, 03037, Ukraine
  • Public Non-Profit Enterprise 'Ternopil Regional Clinical Oncology Center'' under Temopil Regional Council
    Ternopil', 46023, Ukraine
  • Medical Center of Limited Liability Company "ONCOLIFE"
    Zaporizhzhya, 69059, Ukraine
08

References and documents

Study documents

  • Study protocol · Jul 13, 2022
  • Statistical analysis plan · May 15, 2023

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03743064
Lead sponsor
Helsinn Healthcare SA
Responsible party
Sponsor
First posted
Nov 15, 2018
Start date
May 6, 2019
Primary completion
Dec 27, 2022
Completion
Dec 27, 2022
Results posted
Jun 26, 2024
Last update
Jun 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Neoplasms→

Other studies from this sponsor

Helsinn Healthcare SA

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