Trial · NCT05987332
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 2a: To determine the optimal dose of IDE196 + Crizotinib combination for Phase 2B and Phase 3 by evaluating the following: | Approximately 5 months | dose exposure response (safety and efficacy) relationship, plasma concentration profiles and pharmacokinetic (PK) parameters, treatment-emergent Adverse Events (TEAEs), laboratory abnormalities, electrocardiogram (ECG), and vital sign changes and study treatment discontinuation due to AEs. |
| Primary | Phase 2 Progression-Free Survival (PFS) | Approximately 2 years | by blinded independent central review (BICR) of IDE196 + Crizotinib compared to investigator's choice of treatment per RECIST v1.1 |
| Primary | Phase 3 Overall Survival (OS) of IDE196 + Crizotinib compared to investigator's choice of treatment. | Approximately 4 years | OS from randomization to date of death due to any cause |
| Secondary | Safety of IDE196 + Crizotinib: Incidence of Adverse Events | Approximately 2 years | Treatment emergent adverse events will be summarized by all AEs, including by Grade ≥3, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs as measured by CTCAE v5.0. |
| Secondary | Phase 2a: Dose-exposure-response of IDE196 as measured by correlating the concentration of IDE196 in plasma with safety and efficacy. | Approximately 5 months | Dose exposure response of IDE196. |
| Secondary | Phase 2a: Dose-exposure-response of Crizotinib measured by correlating the concentration of Crizotinib in plasma with safety and efficacy. | Approximately 5 months | Dose exposure response of Crizotinib |
| Secondary | Phase 2b + 3: Progression-Free Survival (PFS) per Investigator Assessment of IDE196 + Crizotinib compared to investigator's choice of treatment . | Approximately 2 years | PFS per RECIST v1.1 |
| Secondary | Objective Response Rate (ORR) per BICR and Investigator assessment of IDE196 + Crizotinib compared to investigator's choice of treatment | Approximately 2 years | ORR per RECIST v1.1 |
| Secondary | Duration of Response (DOR) per BICR and Investigator assessment of IDE196 + Crizotinib compared to investigator's choice of treatment | Approximately 2 years | DOR per RECIST v1.1 |
| Secondary | Change from baseline over time and between treatment arms in Global health status and quality of life will be assessed using the EORTC QLQ-C30 questionnaire. | Approximately 2 years | The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related in EORTC QLQ-C30 scores |
| Secondary | Change from baseline over time and between treatment arms in | Approximately 2 years | EuroQoL (EQ)-5D-5L scores |
| Secondary | Best Objective Response (BOR) per BICR and Investigator Assessment of IDE196 + Crizotinib compared to Investigator's choice of treatment | Approximately 2 years | Best Objective Response (BOR) per RECIST v1.1 |
| Secondary | Disease Control Rate (DCR) per BICR and Investigator Assessment of IDE196 + Crizotinib compared to investigator's choice of treatment. | Approximately 2 years | Disease Control Rate (DCR) per RECIST v1.1 |
| Secondary | Time to response as assessed by Investigator and BICR | Approximately 2 years | Time to response per RECIST v1.1 |
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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