Trial · NCT07405190
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 | Objective Response Rate (ORR) of Ivonescimab Monotherapy | Day 1 of cycle 1 (each cycle is 21 days) to disease progression, loss of follow-up, withdrawal of consent, study termination, or for up to 2 years from the day the last patient is enrolled, whichever occurs first. | The objective response rate (ORR) is defined as the number of patients with confirmed best overall response or complete response or partial response (PR) divided by the number of treated patients in the cohort. ORR will be measured per investigator. BOR will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. |
| Primary | Objective Response Rate (ORR) of Ivonescimab plus Carboplatin/Pemetrexed | Day 1 of cycle 1 (each cycle is 21 days) to disease progression, loss of follow-up, withdrawal of consent, study termination, or for up to 2 years from the day the last patient is enrolled, whichever occurs first. | The objective response rate (ORR) is defined as the number of patients with confirmed best overall response or complete response or partial response (PR) divided by the number of treated patients in the cohort. ORR will be measured per investigator. BOR will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. |
| Secondary | Disease Control Rate (DCR) of Ivonescimab Monotherapy | Day 1 of cycle 1 (each cycle is 21 days) to disease progression, loss of follow-up, withdrawal of consent, study termination, or for up to 2 years from the day the last patient is enrolled, whichever occurs first. | Disease control rate (DCR) is defined as the percentage of participants who have either a complete response, partial response, or stable disease. DCR will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. |
| Secondary | Disease Control Rate (DCR) of Ivonescimab plus Carboplatin/Pemetrexed | Day 1 of cycle 1 (each cycle is 21 days) to disease progression, loss of follow-up, withdrawal of consent, study termination, or for up to 2 years from the day the last patient is enrolled, whichever occurs first. | Disease control rate (DCR) is defined as the percentage of participants who have either a complete response, partial response, or stable disease. DCR will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. |
| Secondary | Time to Response (TTR) of Ivonescimab Monotherapy | Day 1 of cycle 1 (each cycle is 21 days) to the first documentation of complete or partial response for up to 2 years from the day the last patient is enrolled. | Time to response (TTR) is defined as the amount of time between the first dose of ivonescimab to the first time that measurement criteria are met for complete response or partial response. TTR will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. |
| Secondary | Time to Response (TRR) of Ivonescimab plus Carboplatin/Pemetrexed | Day 1 of cycle 1 (each cycle is 21 days) to the first documentation of complete or partial response for up to 2 years from the day the last patient is enrolled. | Time to response (TTR) is defined as the amount of time between the first doses of ivonescimab, carboplatin, and pemtrexed to the first time that measurement criteria are met for complete response or partial response. TTR will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. |
| Secondary | Duration of Response (DOR) of Ivonescimab Monotherapy | First day complete or partial response is recorded to the first day progressive disease is recorded or, if no progressive disease occurs, the date of last radiological assessment up to 2 years from the day the last patient is enrolled. | Duration of response (DOR) is defined as the amount of time from the first recording of complete or partial response (whichever is recorded first) to the first date that progressive disease is objectively documented. DOR will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. Patients who do not achieve at least a partial response, will be excluded from the analysis of DOR. |
| Secondary | Duration of Response (DOR) of Ivonescimab plus Carboplatin/Pemetrexed | First day complete or partial response is recorded to the first day progressive disease is recorded or, if no progressive disease occurs, the date of last radiological assessment up to 2 years from the day the last patient is enrolled. | Duration of response (DOR) is defined as the amount of time from the first recording of complete or partial response (whichever is recorded first) to the first date that progressive disease is objectively documented. DOR will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. Patients who do not achieve at least a partial response, will be excluded from the analysis of DOR. |
| Secondary | Progression-Free Survival (PFS) of Ivonescimab Monotherapy | Day 1 of cycle 1 (each cycle is 21 days) to the first day of documented disease progression, death, or if no disease progression or death occurs, the day of the last radiological assessment, up to 2 years from the day the last patient was enrolled. | Progression-free survival (PFS) is defined as the time from the start date of the study drug treatment to the date of first documented progression or death due to any cause. PFS will be assessed will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. PFS will be summarized using the Kaplan-Meier method with median PFS time (including two-sided 95% confidence interval (CI)). The PFS rates at 6 months and at 12 months will be estimated with two-sided 95% CIs. |
| Secondary | Progression-Free Survival (PFS) of Ivonescimab plus Carboplatin/Pemetrexed | Day 1 of cycle 1 (each cycle is 21 days) to the first day of documented disease progression, death, or if no disease progression or death occurs, the day of the last radiological assessment, up to 2 years from the day the last patient was enrolled. | Progression-free survival (PFS) is defined as the time from the start date of the study drug treatment to the date of first documented progression or death due to any cause. PFS will be assessed will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. PFS will be summarized using the Kaplan-Meier method with median PFS time (including two-sided 95% confidence interval (CI)). The PFS rates at 6 months and at 12 months will be estimated with two-sided 95% CIs. |
| Secondary | Overall Survival (OS) of Ivonescimab Monotherapy | Day 1 of cycle 1 (each cycle is 21 days) to death, day of last consent for patients who are lost to follow-up or withdraw, or the study cutoff date for patients will receiving treatment, up to 2 years from the day the last patient was enrolled. | Overall survival (OS) is defined as the time from the start date of the study drug treatment to death due to any cause. OS will be assessed will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. OS will be summarized using the Kaplan-Meier method with median OS time (including two-side 95% confidence interval (CI)). The OS rates at 6, 12, 18, and 24 months will be estimated with two-sided 95% CIs. |
| Secondary | Overall Survival (OS) of Ivonescimab plus Carboplatin/Pemetrexed | Day 1 of cycle 1 (each cycle is 21 days) to death, day of last consent for patients who are lost to follow-up or withdraw, or the study cutoff date for patients will receiving treatment, up to 2 years from the day the last patient was enrolled. | Overall survival (OS) is defined as the time from the start date of the study drug treatment to death due to any cause. OS will be assessed will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. OS will be summarized using the Kaplan-Meier method with median OS time (including two-side 95% confidence interval (CI)). The OS rates at 6, 12, 18, and 24 months will be estimated with two-sided 95% CIs. |
| Secondary | Number of Patients who Experience Adverse Events and Serious Adverse Events on Ivonescimab Monotherapy | Day 1 of cycle 1 (each cycle is 21 days) to the day 90 follow-up visit. | The number of patients with treatment-emergent and treatment-related adverse events (AEs) and serious AEs (SAEs) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0. The number and percentage of participants who experience any AE, SAE, treatment-related AE, and treatment-related SAE will be summarized according to worst toxicity grades. |
| Secondary | Number of Patients who Experience Adverse Events and Serious Adverse Events on Ivonescimab plus Carboplatin/Pemetrexed | Day 1 of cycle 1 (each cycle is 21 days) to the day 90 follow-up visit. | The number of patients with treatment-emergent and treatment-related adverse events (AEs) and serious AEs (SAEs) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0. The number and percentage of participants who experience any AE, SAE, treatment-related AE, and treatment-related SAE will be summarized according to worst toxicity grades. |
| Secondary | Number of Patients who Experience Immune-Related and Especially Interesting Adverse Events on Ivonescimab Monotherapy | Day 1 of cycle 1 (each cycle is 21 days) to the 90 day follow-up visit. | Frequency, management, and resolution of select immune-related adverse events (irAEs) and adverse events of special interest (AESIs) will be analyzed. Time-to onset, severity, duration of irAEs and AESIs, action taken with the study drug, dosing delays, corticosteroid details, and re-challenge information will be recorded. |
| Secondary | Number of Patients who Experience Immune-Related and Especially Interesting Adverse Events on Ivonescimab plus Carboplatin/Pemetrexed | Day 1 of cycle 1 (each cycle is 21 days) to the 90 day follow-up visit. | Frequency, management, and resolution of select immune-related adverse events (irAEs) and adverse events of special interest (AESIs) will be analyzed. Time-to onset, severity, duration of irAEs and AESIs, action taken with the study drug, dosing delays, corticosteroid details, and re-challenge information will be recorded. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07405190/registered