Is a clinical trial planned for daraxonrasib (investigational therapy) in the treatment of local recurrence of pancreatic ductal adenocarcinoma (PDAC)?

Clinical Trials for Daraxonrasib in Local Recurrence of PDAC

There is currently no specific clinical trial planned for daraxonrasib in the treatment of local recurrence of pancreatic ductal adenocarcinoma (PDAC) based on the available evidence.

Current Status of Clinical Trials for PDAC Recurrence

The available guidelines do not mention any specific planned trials for daraxonrasib in locally recurrent PDAC. The most recent guidelines from the National Comprehensive Cancer Network (NCCN) and other major oncology organizations emphasize:

• Clinical trials are the preferred option for all cases of recurrent PDAC 1
• Patient enrollment in clinical trials should be guided by specific tumor genetic profiles 2
• Trials should focus on homogeneous patient populations with respect to disease stage 1

Management Recommendations for Locally Recurrent PDAC

For patients with local recurrence of PDAC, the current approach includes:

1. Confirmatory biopsy (category 2B recommendation) 1
2. Treatment options based on time since adjuvant therapy:
   • If <6 months: Alternative chemotherapy regimen
   • If >6 months: Same systemic therapy as previously administered 1
3. Chemoradiation if not previously administered for local-only recurrence 1

Clinical Trial Design Considerations for PDAC

The NCCN guidelines emphasize specific principles for clinical trial design in pancreatic cancer:

• Trials should incorporate principles of molecular biology and new imaging methods 1
• Tumor tissue banking with paired blood and serum samples should be required 1
• Biomarkers that serve as surrogate markers should be sought 1
• Phase III trials should not be initiated without meaningful efficacy signals in phase II 1
• Primary endpoint should be overall survival 1

Recommendations for Patients with Locally Recurrent PDAC

Given the absence of specific daraxonrasib trials for local recurrence:

1. Seek enrollment in available clinical trials based on tumor genetic profile 2
2. Consider molecular profiling to identify targetable alterations 2
3. Standard treatment options include:
   • Gemcitabine-based regimens
   • Fluoropyrimidine-based regimens
   • FOLFIRINOX for patients with good performance status 2

Key Considerations for Future Trials

For future trials in locally recurrent PDAC, including potential daraxonrasib studies:

• Separate trials should be designed for locally advanced disease versus metastatic disease 1
• Patient selection should account for the putative differential efficacy of the agent 1
• Quality control standards for imaging interpretation and pathologic assessment are critical 1
• Treatment at high-volume centers with multidisciplinary consultation is preferred 2

While daraxonrasib may be studied in pancreatic cancer in the future, current guidelines and evidence do not indicate any specific planned trials for this agent in locally recurrent PDAC.