Trial · NCT07524257
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) by BICR (RECIST v1.1) | Imaging every 9 weeks (±7 days) from first dose (after initial assessments at week 6 and week 12) until treatment discontinuation; final PFS analysis with follow-up through 156 weeks (3 years) from first dose. | PFS is defined as the time from randomization to the first documentation of disease progression per RECIST v1.1 by blinded independent central review (BICR) or death from any cause, whichever occurs first. |
| Secondary | Overall survival (OS) | From first dose until death, with survival follow-up through 156 weeks (3 years) from first dose. | Time from randomization to death from any cause. |
| Secondary | Objective Response Rate (ORR) by BICR (RECIST v1.1) | Imaging every 9 weeks (±7 days) from first dose (after initial assessments at week 6 and week 12) until treatment discontinuation; ORR assessed up to 156 weeks (3 years) from first dose. | ORR is the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by BICR. |
| Secondary | Change in Absolute Lymphocyte Count (ALC) Over Time | At scheduled study visits from first dose through 156 weeks (3 years) from first dose or end of treatment, whichever occurs first. | Change from baseline in absolute lymphocyte count over time by treatment group. |
| Secondary | Duration of Immune Competence (ALC ≥1,000 cells/µL) | From first dose until treatment discontinuation; duration of immune competence assessed up to 156 weeks (3 years) from first dose. | Duration of immune competence, defined as the time during treatment that ALC remains ≥1,000 cells/µL. |
| Secondary | Duration of Response (DOR) by BICR (RECIST v1.1) | Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; DOR assessed up to 156 weeks (3 years) from first dose. | For participants with a confirmed CR or PR per RECIST v1.1 by BICR, DOR is defined as the time from the date of first documented response (CR or PR) to the date of disease progression per RECIST v1.1 by BICR or death from any cause, whichever occurs first. |
| Secondary | Disease Control Rate (DCR) by BICR (RECIST v1.1) | Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; DCR assessed up to 156 weeks (3 years) from first dose. | DCR is the proportion of participants with CR, PR, or stable disease (SD) lasting at least 2 months per RECIST v1.1 as assessed by BICR. |
| Secondary | PFS, ORR, DOR, and DCR by BICR Using iRECIST | Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; each endpoint assessed up to 156 weeks (3 years) from first dose. | PFS, ORR, DOR, and DCR assessed per immune RECIST (iRECIST) as determined by BICR, using the same definitions as for RECIST v1.1 but applying iRECIST rules. |
| Secondary | PFS, ORR, DOR, and DCR by Investigator Assessment (RECIST v1.1 and iRECIST) | Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; each endpoint assessed up to 156 weeks (3 years) from first dose. | PFS, ORR, DOR, and DCR per RECIST v1.1 and iRECIST as assessed by site Investigators, using the same definitions as for BICR. |
| Secondary | Disease-specific survival (DSS) | From first dose until death due to NSCLC, with follow-up through 156 weeks (3 years) from first dose. | DSS is defined as the time from randomization to death due to NSCLC. Deaths from other causes are censored at the date of death. |
| Other | Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From signing of informed consent through 30 days after last dose of study drug; SAEs considered related to study treatment may be collected beyond this window, up to 156 weeks (3 years) from first dose for analysis. | Number and proportion of participants with TEAEs and SAEs, graded using NCI CTCAE v6.0. |
| Other | Changes in Clinical Laboratory Parameters | From first dose through 156 weeks (3 years) from first dose or 30 days after last dose, whichever occurs first. | Changes from baseline in hematology, chemistry, and urinalysis parameters, including ALC. |
| Other | Changes in Vital Signs | From first dose through 156 weeks (3 years) from first dose or 30 days after last dose, whichever occurs first. | Changes from baseline in temperature, heart rate, blood pressure, and respiratory rate. |
| Other | Changes in Electrocardiograms (ECGs) | From first dose through 156 weeks (3 years) from first dose or 30 days after last dose, whichever occurs first. | Incidence of new or worsening clinically relevant ECG abnormalities compared with baseline. |
| Other | Correlation of Whole Slide Images With Clinical Outcomes | From first dose through 156 weeks (3 years) from first dose. | Associations between histopathologic features derived from high-resolution whole slide images and clinical outcomes (PFS, OS, ORR, DOR, DCR). |
| Other | Correlation of Molecular Profiles With Clinical Outcomes | From first dose through 156 weeks (3 years) from first dose. | Associations between tumor and blood-based molecular profiles (e.g., genomic and RNA analyses) and clinical outcomes (PFS, OS, ORR, DOR, DCR, ALC dynamics). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07524257/registered