Trial · NCT04222972
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT04222972, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2026-03-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT04222972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04222972
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT04222972
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 223 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Disease, Carcinoma, Bronchogenic, Bronchial Diseases, Head and Neck Neoplasms, Adenocarcinoma, Carcinoma, Neoplasms by Histologic Type, Neoplasms, Germ Cell and Embryonal, Neoplasms, Nerve Tissue
- Interventions
- Pralsetinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab, Gemcitabine, Paclitaxel, Nab-Paclitaxel
- First posted
- 2020-01-10
- Last updated
- 2026-03-05
- Other registries' IDs
- eudract:2019-002463-10
- Results first posted
- 2026-03-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arm A vs Arm B: Treatment Period: Progression-free Survival (PFS) | Up to approximately 50 months | PFS was defined as the time from randomization to the date of first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (K-M) method was used to estimate median PFS. 95% CI for median was computed using the method of Brookmeyer and Crowley. |
| Secondary | Arm A vs Arm B: Objective Response Rate (ORR) | Up to approximately 50 months | ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off. |
| Secondary | Arm A vs Arm B: Overall Survival (OS) | From randomization to death (up to approximately 50 months) | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. 95% CI for median was computed using the method of Brookmeyer and Crowley. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 50 months | An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. |
| Secondary | Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score | Baseline up to 50 months | ECOG is a 6-point scale (0-5) used to assess participants functional status, where, 0= Fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2= ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. |
| Secondary | Arm A vs Arm B: Duration of Response (DOR) | Up to approximately 50 months | DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate median DOR. 95% CI for median was computed using the method of Brookmeyer and Crowley. |
| Secondary | Arm A vs Arm B: Clinical Benefit Rate (CBR) | Up to approximately 50 months | CBR was defined as the percentage of participants who experienced the best response of stable disease (SD) with a minimum duration of 6 months, a CR, or a PR, as assessed by investigator with use of RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages are rounded off. |
| Secondary | Arm A vs Arm B: Disease Control Rate (DCR) | Up to approximately 50 months | DCR was defined as the percentage of participants who experienced the best response of CR, or PR, or SD, as assessed by investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages are rounded off. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Arm A vs Arm B: Treatment Period: Progression-free Survival (PFS) | Up to approximately 50 months | ITT population included all randomized participants whether or not the assigned study treatment was received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens. | months | MEDIAN |
| SECONDARY | Arm A vs Arm B: Objective Response Rate (ORR) | Up to approximately 50 months | ITT population included all randomized participants whether or not the assigned study treatment is received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens. | percentage of participants | NUMBER |
| SECONDARY | Arm A vs Arm B: Overall Survival (OS) | From randomization to death (up to approximately 50 months) | ITT population included all randomized participants whether or not the assigned study treatment was received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens. | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 50 months | Safety-evaluable population included all participants who receive any amount of any study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score | Baseline up to 50 months | Safety-evaluable population included all participants who receive any amount of any study drug. As specified in the protocol, assessment of this outcome measure was limited to the treatment period, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Arm A vs Arm B: Duration of Response (DOR) | Up to approximately 50 months | ITT population included all randomized participants whether or not the assigned study treatment is received. Overall number analyzed is the number of participants with an objective response of CR or PR. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens. | months | MEDIAN |
| SECONDARY | Arm A vs Arm B: Clinical Benefit Rate (CBR) | Up to approximately 50 months | ITT population included all randomized participants whether or not the assigned study treatment is received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens. | percentage of participants | NUMBER |
| SECONDARY | Arm A vs Arm B: Disease Control Rate (DCR) | Up to approximately 50 months | ITT population included all randomized participants whether or not the assigned study treatment is received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Arm A vs Arm B: Treatment Period: Progression-free Survival (PFS) | Arm A: Treatment Period- SOC | 9.0 | 95% Confidence Interval 7.1 to 11.5 | months | |
| Arm A vs Arm B: Treatment Period: Progression-free Survival (PFS) | Arm B: Treatment Period- Pralsetinib | 18.7 | 95% Confidence Interval 11.1 to 25.2 | months | |
| Arm A vs Arm B: Objective Response Rate (ORR) | Arm A: Treatment Period- SOC | 41.6 | 95% Confidence Interval 32.40 to 51.24 | percentage of participants | |
| Arm A vs Arm B: Objective Response Rate (ORR) | Arm B: Treatment Period- Pralsetinib | 65.5 | 95% Confidence Interval 55.79 to 74.26 | percentage of participants | |
| Arm A vs Arm B: Overall Survival (OS) | Arm A: Treatment Period- SOC | 39.8 | 95% Confidence Interval 39.8 to NA | months | |
| Arm A vs Arm B: Overall Survival (OS) | Arm B: Treatment Period- Pralsetinib | NA | 95% Confidence Interval 29.6 to NA | months | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Arm A: Treatment Period- SOC | AEs | 104 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Arm B: Treatment Period- Pralsetinib | AEs | 108 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Arm C: Crossover Period- Pralsetinib | AEs | 38 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Arm A: Treatment Period- SOC | SAEs | 38 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Arm A: Treatment Period- SOC | 113 | |
| Treatment Period | STARTED | Arm B: Treatment Period- Pralsetinib | 110 | |
| Treatment Period | STARTED | Arm C: Crossover Period- Pralsetinib | 0 | |
| Treatment Period | Safety-evaluable Population | Arm A: Treatment Period- SOC | 104 | |
| Treatment Period | Safety-evaluable Population | Arm B: Treatment Period- Pralsetinib | 108 | |
| Treatment Period | Safety-evaluable Population | Arm C: Crossover Period- Pralsetinib | 0 | |
| Treatment Period | COMPLETED | Arm A: Treatment Period- SOC | 0 | |
| Treatment Period | COMPLETED | Arm B: Treatment Period- Pralsetinib | 0 | |
| Treatment Period | COMPLETED | Arm C: Crossover Period- Pralsetinib | 0 | |
| Treatment Period | NOT COMPLETED | Arm A: Treatment Period- SOC | 113 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events645
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 | Anaemia | Blood and lymphatic system disorders | Arm A: Treatment Period- SOC | 47 | 104 | 63 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Treatment Period- Pralsetinib | 52 | 108 | 71 |
| other | Anaemia | Blood and lymphatic system disorders | Arm C: Crossover Period- Pralsetinib | 10 | 38 | 13 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Treatment Period- SOC | 5 | 104 | 5 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: Treatment Period- Pralsetinib | 13 | 108 | 16 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm C: Crossover Period- Pralsetinib | 2 | 38 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm A: Treatment Period- SOC | 2 | 104 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm B: Treatment Period- Pralsetinib | 6 | 108 | 7 |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm C: Crossover Period- Pralsetinib | 3 | 38 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Treatment Period- SOC | 19 | 104 | 31 |
1 to 10 of 645Source ClinicalTrials.gov
See all 645 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Treatment Period- SOC | 27 | 113 |
| Total, all-cause mortality | Arm B: Treatment Period- Pralsetinib | 33 | 110 |
| Total, all-cause mortality | Arm C: Crossover Period- Pralsetinib | 8 | 38 |
| Total, other adverse events | Arm A: Treatment Period- SOC | 103 | 104 |
| Total, other adverse events | Arm B: Treatment Period- Pralsetinib | 106 | 108 |
| Total, other adverse events | Arm C: Crossover Period- Pralsetinib | 38 | 38 |
| Total, serious adverse events | Arm A: Treatment Period- SOC | 38 | 104 |
| Total, serious adverse events | Arm B: Treatment Period- Pralsetinib | 67 | 108 |
| Total, serious adverse events | Arm C: Crossover Period- Pralsetinib | 22 | 38 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04222972
GET https://conductscience.org/api/trials/v1/NCT04222972/results?page=2