Chemotherapy with or without INCB161734 for untreated KRAS G12D metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 study compares standard investigator‑choice chemotherapy given with either the oral KRAS G12D inhibitor INCB161734 or matching placebo in participants with metastatic pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation. Eligible patients must be systemic treatment–naïve in the metastatic setting, have ECOG performance status 0–1, and meet organ function requirements. Participants are assigned to one of the two arms and followed for safety, tumor response, and survival outcomes. The protocol excludes prior KRAS inhibitor exposure and active central nervous system metastases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation
* No prior systemic treatment in the metastatic setting
* ECOG Performance status 0-1
* Adequate organ function

Exclusion Criteria:

* Prior treatment with any KRAS inhibitor
* Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug
* Known active CNS metastases

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where it's running

• Investigative Site US016
  Anchorage, Alaska, United States Recruiting
• Investigative Site US026
  Chandler, Arizona, United States Recruiting
• Investigative Site US051
  Duarte, California, United States Recruiting
• Investigative Site US027
  Los Angeles, California, United States Recruiting
• Investigative Site US036
  Los Angeles, California, United States Recruiting
• Investigative Site US048
  Los Angeles, California, United States Recruiting

+180 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.