TriangleNCT05714553 · OUTCOME
Number of Patients Achieving a Reduction in Tumour Volume (Objective Response Rate; ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Assessed from baseline to 30 days after last dose of study drug, up to 20 months
What was measured
Objective response rate, defined as the percentage of patients achieving a complete (CR) or partial response (PR) to treatment. Response was measured by MRI scan and assessed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria in Module 2 and by immune RECIST (iRECIST) criteria in Module 1: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions
Analysis population: The evaluable for response population was used and included all patients with measurable disease at baseline who had undergone at least two cycles of treatment, received at least 75% of planned treatment over the two cycles, and undergone a post-treatment objective disease assessment.
Groups in this outcome
Module 1 (NUC-3373 + LV + Pembrolizumab)
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase). NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
Module 2 (NUC-3373 + LV + Docetaxel)
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase). NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
| Group | Source count |
|---|---|
| Module 1 (NUC-3373 + LV + Pembrolizumab) | 9 |
| Module 2 (NUC-3373 + LV + Docetaxel) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Module 1 (NUC-3373 + LV + Pembrolizumab) | 2 | Not reported | Not reported | Not reported | Not reported |
| Module 2 (NUC-3373 + LV + Docetaxel) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Objective response rate, defined as the percentage of patients achieving a complete (CR) or partial response (PR) to treatment. Response was measured by MRI scan and assessed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria in Module 2 and by immune RECIST (iRECIST) criteria in Module 1: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions
- groups
- description
- This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase). NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
- id
- OG000
- title
- Module 1 (NUC-3373 + LV + Pembrolizumab)
- description
- This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase). NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
- id
- OG001
- title
- Module 2 (NUC-3373 + LV + Docetaxel)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The evaluable for response population was used and included all patients with measurable disease at baseline who had undergone at least two cycles of treatment, received at least 75% of planned treatment over the two cycles, and undergone a post-treatment objective disease assessment.
- reporting Status
- POSTED
- time Frame
- Assessed from baseline to 30 days after last dose of study drug, up to 20 months
- title
- Number of Patients Achieving a Reduction in Tumour Volume (Objective Response Rate; ORR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice