Trial · NCT06552234
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) according to RECIST v1.1. | From the date of first treatment administration until the date of disease progression or death if patient died before progression) or the introduction of a new treatment, which ever occurs earlier, assessed up to 7 years | ORR defined as the proportion of patients who achieved a complete or partial response according to RECIST v1.1 from the date of first treatment administration until disease progression or death if patient died before progression or the introduction of a new treatment assessed by blinded independent central review. Tumor assessments will be performed at Screening, every 2 Months during the first year then every 3 months thereafter until documented progression, death or the introduction of a new treatment. Patients who discontinue treatment for reasons other than radiographic disease progression per RECIST v1.1 (toxicity, symptomatic deterioration) will continue scheduled tumor assessments until radiographic disease progression per RECIST v1.1, withdrawal of consent, death, or study termination by the co-Sponsors, whichever occurs first |
| Secondary | Progression free survival (PFS) by masked, independent central review | From the date of first treatment administration until the date of disease progression (or death if patient died before progression), which ever occurs earlier, assessed up to 7 years | Independent central review of progression free survival (PFS) from Repotrectinib initiation, defined as the time from first dose of Repotrectinib to first documentation of objective disease progression (RECIST v1.1) or to death from any cause. Patients lost to follow-up will be censored as the last date of radiological assessment without progression. Tumor assessments will be performed at Screening, every 2 Months during the first year then every 3 months thereafter until documented progression, death or the introduction of a new treatment. Patients who discontinue treatment for reasons other than radiographic disease progression per RECIST v1.1 (e.g., toxicity, symptomatic deterioration) will continue scheduled tumor assessments until radiographic disease progression per RECIST v1.1, withdrawal of consent, death, or study termination by the co-Sponsors, whichever occurs first. |
| Secondary | Disease control rate (DCR) by masked, independent central review | From the date of first treatment administration until the date of disease progression (or death if patient died before progression), which ever occurs earlier, assessed up to 7 years | DCR, defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v1.1 assessed by BICR. Tumor assessments will be performed at Screening, every 2 Months during the first year then every 3 months thereafter until documented progression, death or the introduction of a new treatment. Patients who discontinue treatment for reasons other than radiographic disease progression per RECIST v1.1 (e.g., toxicity, symptomatic deterioration) will continue scheduled tumor assessments until radiographic disease progression per RECIST v1.1, withdrawal of consent, death, or study termination by the co-Sponsors, whichever occurs first. |
| Secondary | Intracranial ORR (ic-ORR) by masked, independent central review | From the date of first treatment administration until the date of disease progression (or death if patient died before progression), which ever occurs earlier, assessed up to 7 years | ic-ORR, defined as the proportion of patients who achieved CR or PR in measurable brain metastases based on RECIST 1.1 criteria |
| Secondary | Overall survival (OS) | From the date of first treatment administration until the date of death from any cause, assessed up to 7 years | OS, defined as the time from first dose of Repotrectinib until death from any cause. Patients lost to follow-up will be censored at the last date known to be alive. OS will be evaluated every 3 months (until death or lost to follow-up) in patients who: * Discontinue the study treatment due to disease progression * Discontinue the study treatment due to an unacceptable toxicity or any other reason, and who start a new therapy * Reach the End-of-study Time Point. |
| Secondary | Toxicities occurring during either the induction or maintenance treatment in terms of kind, grade, time of onset, reversibility, according to NCI-CTCAE v5.0 criteria | From the date of first treatment administration up to 30 days after the last dose of study treatment | Proportion (%) of patients with any adverse event (AE) and number of events for all AEs, all serious AEs (SAEs) and all AEs of grade ≥3 according to the National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) v5.0 criteria. |
| Secondary | Duration of response (DOR) assessed in patients who had an objective response as determined by the investigator using RECIST v1.1 | From the date of first documented objective response (CR or PR) until disease progression or death, which ever occurs earlier, assessed up to 7 years | DOR, defined as the time from the first documented objective response (CR or PR) until disease progression or death, whichever occurs first. |
| Secondary | Time to deterioration in lung-related symptoms | From the date of inclusion to the date the patient's score on the EORTC QLQ C30 or QLQ-LC13 shows a ≥10-point increase above baseline, assessed up to 7 years | Time to deterioration in lung-related symptoms, defined as the time from inclusion to the time the patient's score on the EORTC QLQ C30 or QLQ-LC13 shows a ≥10-point increase above baseline in each of the following EORTC-transformed scores for cough, dyspnea (single item), dyspnea (multi-item subscale) and chest pain. Patients lost to follow-up without previous QOL deterioration will be censored at the last EORTC assessment date. QoL/PRO questionnaires may be filled out up until D1 every 8 weeks ±7 days during the first year, then every 12 weeks ±7 days thereafter at Progression. |
| Secondary | Time to deterioration in quality of life | From the date of inclusion to the date the patient's score on the EQ-5D-3L utility score shows a 0.08 point decrease above baseline, assessed up to 7 years | Time to deterioration in quality of life, defined as the time from inclusion to the time the patient's score on the EQ-5D-3L utility score shows a 0.08 point decrease above baseline. Patients lost to follow-up without previous EQ-5D-3L deterioration will be censored at the last EQ-5D-3L assessment. QoL/PRO questionnaires may be filled out up until D1 every 8 weeks ±7 days during the first year, then every 12 weeks ±7 days thereafter at Progression. |
| Secondary | PFS subgroup analysis according to Performance Status and age | From the date of first treatment administration until the date of disease progression (or death if patient died before progression), which ever occurs earlier, assessed up to 7 years | PFS according to different subgroups : * PS ≥ 2 at the time of inclusion * Age ≥ 70 years |
| Secondary | OS subgroup analysis according to Performance Status and age | From the date of first treatment administration until the date of death from any cause, assessed up to 7 years | OS according to different subgroups : * PS ≥ 2 at the time of inclusion * Age ≥ 70 years |
| Secondary | ORR subgroup analysis according to Performance Status and age | From the date of first treatment administration until the date of disease progression or death if patient died before progression) or the introduction of a new treatment, which ever occurs earlier, assessed up to 7 years | ORR according to different subgroups : * PS ≥ 2 at the time of inclusion * Age ≥ 70 years |
| Secondary | DCR subgroup analysis according to Performance Status and age | From the date of first treatment administration until the date of disease progression (or death if patient died before progression), which ever occurs earlier, assessed up to 7 years | DCR according to different subgroups : * PS ≥ 2 at the time of inclusion * Age ≥ 70 years |
| Secondary | ic-ORR subgroup analysis according to Performance Status and age | From the date of first treatment administration until the date of disease progression (or death if patient died before progression), which ever occurs earlier, assessed up to 7 years | ic-ORR according to different subgroups : * PS ≥ 2 at the time of inclusion * Age ≥ 70 years |
| Secondary | DOR subgroup analysis according to Performance Status and age | From the date of first documented objective response (CR or PR) until disease progression or death, which ever occurs earlier, assessed up to 7 years | DOR according to different subgroups : * PS ≥ 2 at the time of inclusion * Age ≥ 70 years |
| Secondary | Duration of study treatment subgroup analysis according to Performance Status and age | From the date of first treatment administration until the date of last treatment administration, up to 7 years | Duration of treatment according to different subgroups : * PS ≥ 2 at the time of inclusion * Age ≥ 70 years |
| Secondary | Toxicities occurring during study treatment assessed by the NCI-CTCAE v5.0, analysed in subgroups according to Performance Status and age | From the date of first treatment administration up to 30 days after the last dose of study treatment | Proportion (%) of patients with any AE and number of events for all AEs, all SAEs and all AEs of grade ≥3 assessed by the NCI-CTCAE v5.0 criteria, according to different subgroups : * PS ≥ 2 at the time of inclusion * Age ≥ 70 years |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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