Trial · NCT06477523
Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC
NCT06477523, Phase 1, Phase 2, Active not recruiting, Sichuan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC. Trials, record NCT06477523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06477523
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC
- NCT number
- NCT06477523
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 57 participants, estimated
- Lead sponsor
- Sichuan University
- Conditions
- SCLC, Extensive Stage
- Interventions
- AK104, Etoposide, Carboplatin, low-dose radiotherapy
- First posted
- 2024-06-27
- Last updated
- 2026-04-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-related adverse events | 48 months | The incidence of treatment-related adverse events were measured for determining tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Events of grade 3-5 are defined as moderate and severe adverse events. |
| Primary | Progression free survival at 6 months (PFS-6) | 6 months | PFS-6 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients achieving progression-free status at 6 months from diagnosis. |
| Secondary | Disease control rate (DCR) | Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years | DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST V1.1 |
| Secondary | Progression free survival (PFS) | Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 24 months. | PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first) |
| Secondary | PFS Rates at 12 months (PFS-12) | 12 months. | PFS-6 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients achieving progression-free status at 12 months from diagnosis. |
| Secondary | Overall survival (OS) | Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 24 months. | OS is defined as the time from randomization to death. |
| Secondary | OS Rates at 12 Months (OS-12) | 12 months | OS-12 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients survival at 12 months from diagnosis. |
| Secondary | OS Rates at 24 Months ( OS-24) | 24 months | OS-24 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients survival at 24 months from diagnosis. |
| Secondary | Objective Response Rate (ORR) | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 18 months. | ORR is proportion of subjects with complete response(CR) or partial response(PR). Tumor responses will be evaluated according to RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders. |
| Secondary | Number of participants with adverse events (AEs) | From the subject signs the Informed Consent Form to 90 days after the last dose of study treatment or initiation of other anti-tumor therapy | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. temporally associated with the use of study treatment, whether or not considered related to the study treatment |
Source ClinicalTrials.gov
Outcomes0
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.
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/NCT06477523
GET https://conductscience.org/api/trials/v1/NCT06477523/registered