Trial · NCT07566052
A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation
NCT07566052, Phase 3, Recruiting, Astellas Pharma Global Development, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation. Trials, record NCT07566052. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07566052
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation
- NCT number
- NCT07566052
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 356 participants, estimated
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Setidegrasib, Docetaxel
- First posted
- 2026-05-04
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. as assessed by blinded independent central review (BICR) | Up to 2.3 years | PFS is defined as the time from the date of randomization until the date of documented radiographic disease progression per RECIST v1.1, as assessed by BICR or until death due to any cause, whichever comes first. |
| Primary | Overall Survival (OS) | Up to 4.2 years | OS is defined as the time from the date of randomization until the date of death from any cause. |
| Secondary | Time to deterioration in NSCLC symptoms (TDLCS): cough evaluated via European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) items | Up to 2.3 years | TDLCS: cough is defined as time between randomization and the first occurrence of a meaningful deterioration in the corresponding EORTC QLQ-LC13 coughing score (item 31) compared with the baseline score. EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It consists of 3 items to assess dyspnea, and 10 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | TDLCS: chest pain evaluated via EORTC QLQ-LC13 | Up to 2.3 years | TDLCS: chest pain is defined as the time between randomization and the first occurrence of a meaningful deterioration in the EORTC QLQ-LC13 chest pain score (item 40) compared with the baseline score. EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It consists of 3 items to assess dyspnea, and 10 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | TDLCS: dyspnea evaluated via EORTC QLQ-LC13 | Up to 2.3 years | TDLCS: dyspnea is defined as the time between randomization and the first occurrence of a meaningful deterioration in the EORTC QLQ-LC13 dyspnea score (composite of items 33 to 35) compared with the baseline score. EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It consists of 3 items (items 33 to 35) to assess dyspnea, and 10 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | Time to Worsening of Global Health Status/Quality of Life (GHS/QoL) (TWGQ) measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Up to 2.3 years | TWGQ is defined as time between randomization and the first occurrence of a meaningful worsening in the composite EORTC QLQ-C30 item scores (19 and 30) compared with the baseline score. EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms. |
| Secondary | Objective Response Rate (ORR) per RECIST v1.1, as assessed by BICR | Up to 2.3 years | ORR is defined as the proportion of participants whose best overall response (BOR) is rated as confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1. as assessed by BICR. |
| Secondary | Time to response (TTR) per RECIST v 1.1 as assessed as assessed by BICR | Up to 2.3 years | TTR is defined as the time from the date of randomization to the first documentation of objective response (confirmed CR or confirmed PR) per RECIST v1.1. as assessed by BICR. |
| Secondary | Duration of Response (DOR) per RECIST v 1.1 as assessed by BICR | Up to 2.3 years | DOR is defined as the time from the date of first documented response (CR or PR subsequently confirmed) to the date of first documented PD per RECIST v1.1 assessed by BICR, or death due to any cause, whichever occurs first. |
| Secondary | Disease Control Rate (DCR) per RECIST v 1.1 as assessed by BICR | Up to 2.3 years | DCR is defined as the proportion of participants whose best overall response is rated as CR, confirmed PR or SD per RECIST v1.1 as assessed by BICR. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07566052
GET https://conductscience.org/api/trials/v1/NCT07566052/registered?page=2