Pamrevlumab + Chemotherapy for Pancreatic Cancer (LAPIS Trial)

Recruiting in Palo Alto (17 mi)

+94 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: FibroGen

Stay on your current meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing pamrevlumab with standard chemotherapy in patients with advanced pancreatic cancer that can't be surgically removed. The goal is to see if the new drug can help shrink tumors enough to make surgery possible.

Eligibility Criteria

Adults over 18 with locally advanced, unresectable pancreatic cancer can join this trial. They must have good organ function, no recent other cancers (except certain skin cancers), and not be on drugs affecting liver enzymes. Participants need to use effective contraception and cannot be pregnant or breastfeeding.

Participant Groups

The trial is testing the safety and effectiveness of a new drug called Pamrevlumab combined with chemotherapy (Gemcitabine plus Nab-paclitaxel or FOLFIRINOX) compared to placebo with the same chemotherapies in treating pancreatic cancer before surgery.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment1 Intervention

Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX

Group II: Arm BPlacebo Group1 Intervention

Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX

FOLFIRINOX is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as FOLFIRINOX for: