Trial · NCT03743064
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) - 2
NCT03743064, Phase 3, Completed, Helsinn Healthcare SA; results first posted 2024-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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) - 2. Trials, record NCT03743064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03743064
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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) - 2
- NCT number
- NCT03743064
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 318 participants, actual
- Lead sponsor
- Helsinn Healthcare SA
- Conditions
- Cachexia; Cancer, Non Small Cell Lung Cancer
- Interventions
- anamorelin HCl, Placebo Oral Tablet
- First posted
- 2018-11-15
- Last updated
- 2026-10-06
- Other registries' IDs
- eudract:2018-002927-40
- Results first posted
- 2024-06-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Body Weight Over 12 Weeks | Mean change from baseline 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. |
| Primary | Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks | Mean change from baseline 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. |
| Secondary | Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg) | Duration of treatment benefit from baseline over 12 weeks. | 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. |
| Secondary | Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg) | Duration of treatment benefit from baseline over 12 weeks. | 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. |
| Secondary | Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points) | Duration of treatment benefit from baseline over 12 weeks. | 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. |
| Secondary | Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points) | Duration of treatment benefit from baseline over 12 weeks. | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Body Weight Over 12 Weeks | Mean change from baseline over 12 weeks. | The Intent-to-Treat (ITT) Set included all randomized patients and was analyzed as per planned treatment. | kg | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks | Mean change from baseline over 12 weeks. | The ITT Set included all randomized patients and was analyzed as per planned treatment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg) | Duration of treatment benefit from baseline over 12 weeks. | The ITT Set included all randomized patients and was analyzed as per planned treatment. | weeks | LEAST_SQUARES_MEAN |
| SECONDARY | Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg) | Duration of treatment benefit from baseline over 12 weeks. | The ITT Set included all randomized patients and was analyzed as per planned treatment. | weeks | LEAST_SQUARES_MEAN |
| SECONDARY | Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points) | Duration of treatment benefit from baseline over 12 weeks. | The ITT Set included all randomized patients and was analyzed as per planned treatment. | weeks | LEAST_SQUARES_MEAN |
| SECONDARY | Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points) | Duration of treatment benefit from baseline over 12 weeks. | The ITT Set included all randomized patients and was analyzed as per planned treatment. | weeks | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Body Weight Over 12 Weeks | 100 mg Anamorelin HCl | 1.822 | Standard Error 0.263 | kg | |
| Mean Change From Baseline in Body Weight Over 12 Weeks | Placebo | 0.538 | Standard Error 0.250 | kg | |
| Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks | 100 mg Anamorelin HCl | 3.432 | Standard Error 0.360 | score on a scale | |
| Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks | Placebo | 3.291 | Standard Error 0.342 | score on a scale | |
| Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg) | 100 mg Anamorelin HCl | 8.859 | Standard Error 0.525 | weeks | |
| Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg) | Placebo | 6.778 | Standard Error 0.496 | weeks | |
| Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg) | 100 mg Anamorelin HCl | 5.490 | Standard Error 0.431 | weeks | |
| Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg) | Placebo | 3.087 | Standard Error 0.409 | weeks | |
| Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points) | 100 mg Anamorelin HCl | 9.470 | Standard Error 0.392 | weeks | |
| Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points) | Placebo | 8.842 | Standard Error 0.370 | weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 100 mg Anamorelin HCl | 154 | |
| Overall Study | STARTED | Placebo | 164 | |
| Overall Study | Treated | 100 mg Anamorelin HCl | 154 | |
| Overall Study | Treated | Placebo | 164 | |
| Overall Study | COMPLETED | 100 mg Anamorelin HCl | 83 | |
| Overall Study | COMPLETED | Placebo | 90 | |
| Overall Study | NOT COMPLETED | 100 mg Anamorelin HCl | 71 | |
| Overall Study | NOT COMPLETED | Placebo | 74 |
Source ClinicalTrials.gov
Adverse events188
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenia | General disorders | 100 mg Anamorelin HCl | 19 | 154 | 24 |
| other | Asthenia | General disorders | Placebo | 22 | 164 | 26 |
| other | Chest Pain | General disorders | 100 mg Anamorelin HCl | 13 | 154 | 14 |
| other | Chest Pain | General disorders | Placebo | 9 | 164 | 10 |
| other | Fatigue | General disorders | 100 mg Anamorelin HCl | 7 | 154 | 7 |
| other | Fatigue | General disorders | Placebo | 2 | 164 | 2 |
| other | Oedema Peripheral | General disorders | 100 mg Anamorelin HCl | 7 | 154 | 9 |
| other | Oedema Peripheral | General disorders | Placebo | 5 | 164 | 8 |
| other | Nausea | Gastrointestinal disorders | 100 mg Anamorelin HCl | 18 | 154 | 28 |
| other | Nausea | Gastrointestinal disorders | Placebo | 12 | 164 | 16 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 100 mg Anamorelin HCl | 25 | 154 |
| Total, all-cause mortality | Placebo | 28 | 164 |
| Total, other adverse events | 100 mg Anamorelin HCl | 114 | 154 |
| Total, other adverse events | Placebo | 127 | 164 |
| Total, serious adverse events | 100 mg Anamorelin HCl | 44 | 154 |
| Total, serious adverse events | Placebo | 46 | 164 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 100 mg Anamorelin HCl vs Placebo: deaths from any cause | Trial comparisons |
| 100 mg Anamorelin HCl vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03743064
GET https://conductscience.org/api/trials/v1/NCT03743064/events?page=2