Recruiting
Phase 1
Phase 2

Gemcitabine, Erlotinib, Nab-paclitaxel

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06483555

Conditions

Pancreatic Adenocarcinoma

Metastatic Pancreatic Cancer

Basal Cell Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gemcitabine

Nab paclitaxel

Erlotinib

NALIRIFOX

Folfirinox

Study Details

Brief summary:

This Phase I/II clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. All participants are first tested with a tool called PurIST, which classifies tumors as either "basal-like" or "classical." People with basal-like tumors will receive GnP plus erlotinib during Phase I so researchers can determine the safest and most effective dose. Once that dose is identified, the study moves to Phase II, where people with basal-like tumors will be randomly assigned to receive either GnP alone or GnP with erlotinib. Phase II may also test new drug combinations if new treatments become approved during the study period. Overall, the trial plans to include up to about 52 basal-like patients in Phase I, roughly 82 basal-like patients in Phase II, and at least 52 classical patients, with the possibility of enrolling more if needed. People whose tumors are classified as classical will continue with standard treatments recommended by their doctors or other clinical trials. Across the entire study, researchers will carefully track long-term outcomes such as overall survival, how long patients live before the cancer progresses, and how well their tumors respond to treatment.

Conditions

Pancreatic Adenocarcinoma

Metastatic Pancreatic Cancer

Basal Cell Neoplasm

Study ID

NCT06483555

Start date

Feb 6, 2025

Status verified date

Apr, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
  • Age ≥ 18 years at the time of consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Histological or cytological evidence/confirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma.
  • The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
  • Subjects may have received prior standard-of-care (SOC) neoadjuvant therapy and may have received up to two cycles of first-line FOLFIRINOX or NALIRIFOX.
  • A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study treatment have been off of corticosteroids for ≥ 2 weeks and are asymptomatic.

Exclusion Criteria:

  • Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1
  • Not having histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma.
  • Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment

Study Design

Enrollment

104 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PurIST Basal

Subjects will be screened using the PurIST classifier and "basal-like" tumors will be assigned combination therapy with GnP and erlotinib.

active comparator: PurIST Classical

Subjects will be screened using the PurIST classifier and with classical tumors will be treated per standard of care on triplet therapy.

Interventions

Gemcitabine

1000 mg/m2, intravenously on day 1 and day 15, for subjects with basal-like cell type pancreatic carcinoma.

Nab paclitaxel

125 mg/m2 intravenously on day 1 and day 15 for subjects with basal-like cell type pancreatic carcinoma.

Erlotinib

50 mg per oral daily. for subjects with basal-like cell type pancreatic carcinoma.

NALIRIFOX

Subjects with classical pancreatic adenocarcinoma will receive. NALIRIFOX is liposomal irinotecan with 5-fluorouracil/leucovorin and oxaliplatin. Dosing and plan will be decided by the treating physician.

Folfirinox

Subjects with classical pancreatic adenocarcinoma will receive. Dosing and plan will be decided by the treating physician.

Primary outcome measure

  • Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: First day of study treatment through the 28 days after last treatment ]
  • Dose-limiting toxicity (DLT) [ Time Frame: Up to 28 days ]
  • Overall survival- classical metastatic pancreatic adenocarcinoma [ Time Frame: 2 years ]
  • Progression-free survival [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Ashwin Somasundaram, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • safety
  • tolerability
  • efficacy
  • EGFR inhibitors
  • gemcitabine
  • nab-paclitaxel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-04-23.