Trial · NCT07902921
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NCT07902921, Phase 1, Phase 2, Not yet recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma. Trials, record NCT07902921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07902921
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
- NCT number
- NCT07902921
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 67 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- NSCLC, Non-Small Cell Lung Cancer, Lung Cancer, Prostate Cancer, Thymic Epithelial Tumors, TETs, Thymic Carcinomas, Thymomas, Metastatic Castrate-resistant Prostate Cancer, mCRPC
- Interventions
- STAR0602, Nivolumab
- First posted
- 2026-10-29
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: Determine the safety of STAR0602 monotherapy in participants with TC, and safety of STAR0602 in combination with nivolumab in participants with NSCLC with or without targetable genomic alterations or mCRPC | Start of therapy through 90 day post last dose safety visit. | The number of adverse events by grade and type will be reported in each cohort along with a 95% confidence interval. Dose-limiting toxicities (DLTs) will also be collected and reported by type, grade, and frequency. |
| Primary | Phase II: Determine the clinical efficacy of STAR0602 alone in participants with TC measured by progression free survival (PFS) | Cycle 3 Day 1, Cycle 4 Day 1, then every 8 weeks for the first year and every 12 weeks thereafter until disease progression, start of another systemic therapy, or 5 years after completion of study treatment. | Proportion of participants attaining progression free survival (PFS) will be evaluated and reported along with a 95% confidence interval. |
| Secondary | To evaluate safety of STAR0602 alone during Phase II | Start of therapy through 90 day post last dose safety visit. | The number of adverse events by grade and type will be reported in each cohort along with a 95% confidence interval. Dose-limiting toxicities (DLTs) will also be collected and reported by type, grade, and frequency. |
| Secondary | To evaluate the efficacy of STAR0602 + nivolumab as defined by progression free survival (PFS) in participants with NSCLC or mCRPC | Cycle 3 Day 1, Cycle 4 Day 1, then every 8 weeks for the first year and every 12 weeks thereafter until disease progression, start of another systemic therapy, or 5 years after completion of study treatment. | Proportion of participants attaining progression free survival (PFS) will be evaluated and reported along with a 95% confidence interval. |
| Secondary | Determine the overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) of STAR0602 + nivolumab in participants with NSCLC or mCRPC | For ORR, DCR, DOR: C3D1, C4D1, then every 8 weeks for 1 year and every 12 weeks thereafter for up to 5 years after end of treatment. For OS: Start of therapy through 5 years after completion of treatment. | Overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) will be calculated as simple proportions from the on-study date and reported along with a 95% confidence interval for the median time if appropriate, or for selected time points such as at 1 or 2 years. |
| Secondary | Determine the overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) of STAR0602 in participants with TC | For ORR, DCR, DOR: C3D1, C4D1, then every 8 weeks for 1 year and every 12 weeks thereafter for up to 5 years after end of treatment. For OS: Start of therapy through 5 years after completion of treatment. | Overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) will be calculated as simple proportions from the on-study date and reported along with a 95% confidence interval for the median time if appropriate, or for selected time points such as at 1 or 2 years. |
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/NCT07902921
GET https://conductscience.org/api/trials/v1/NCT07902921/registered