Trial · NCT06357533
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
NCT06357533, Phase 3, Recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations. Trials, record NCT06357533. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06357533
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
- NCT number
- NCT06357533
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 675 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Datopotamab Deruxtecan, Rilvegostomig, Pembrolizumab
- First posted
- 2024-04-10
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) in TROP2 biomarker positive participants. | Approximately 4 years | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis. |
| Primary | Overall Survival (OS) in TROP2 biomarker positive participants. | Approximately 6 years | OS is defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of OS. |
| Secondary | Progression-Free Survival (PFS) in the FAS population. | Approximately 4 years | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population: • FAS population The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis. |
| Secondary | Overall Survival (OS) in the FAS population. | Approximately 6 years | OS is defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population: • FAS population The measure of interest is the HR of OS. |
| Secondary | Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations | Approximately 4 years | ORR is defined as the proportion of participants who have a CR or PR, as determined by BICR per RECIST 1.1. The analyses will include all randomised participants, as randomised, with measurable disease at baseline, in the following populations: * TROP2 biomarker positive population * FAS population Data obtained from randomisation up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR, regardless of whether the participant withdraws from therapy. Participants who go off treatment without a response or progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR. The measure of interest is the difference of the ORR. ORR by investigator will be reported as a sensitivity analysis. |
| Secondary | Assessment of Duration of Response (DoR) by BICR in TROP2 biomarker positive and FAS populations | Approximately 4 years | DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR or death due to any cause. The analyses will include all randomised participants who have a response, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following populations: * TROP2 biomarker positive population * FAS population The measure of interest is the median of DoR. DoR by investigator will be reported as a sensitivity analysis. |
| Secondary | Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab. | Approximately 6 years | Time to deterioration in: pulmonary symptoms (dyspnoea, cough, and chest pain) as measured by the NSCLC-SAQ, in overall lung cancer symptoms as measured by the NSCLC-SAQ, and in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172. Time to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations: * TROP2 biomarker positive population * FAS population The measure of interest is the HR of time to deterioration in pulmonary symptoms, HR of time to deterioration in overall lung cancer symptoms, and HR of time to deterioration in GHS/QoL. |
| Secondary | Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab. | Approximately 6 years | Time to deterioration in physical functioning as measured by PROMIS Physical Function short form 8c. Time to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations: * TROP2 biomarker positive population * FAS population The measure of interest is the HR of time to deterioration in physical functioning. |
| Secondary | Pharmacokinetics (PK) | Approximately 6 years | Concentration of rilvegostomig, Dato-DXd, total anti TROP2 antibody, and MAAA 1181a (payload deruxtecan) in plasma or serum and PK parameters (peak and trough concentrations). |
| Secondary | Immunogenicity | Approximately 6 years | Presence of ADA for Dato-DXd and rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41669261 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06357533
GET https://conductscience.org/api/trials/v1/NCT06357533/registered