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Chemotherapy

Pamrevlumab + Chemotherapy for Pancreatic Cancer (LAPIS Trial)

Phase 3
Waitlist Available
Research Sponsored by FibroGen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization until disease progression or death, whichever occurs first (assessed up to 6 years)
Awards & highlights

LAPIS Trial Summary

This trial is testing a new cancer treatment on people with pancreatic cancer that has spread and cannot be removed by surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to monoclonal antibodies like Pamrevlumab, as well as those associated with chemotherapy such as fatigue, nausea, low blood counts, peripheral neuropathy (nerve pain), and increased risk of infection.

LAPIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization until disease progression or death, whichever occurs first (assessed up to 6 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization until disease progression or death, whichever occurs first (assessed up to 6 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Best Overall Objective Response Rate (ORR), as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Event-free survival (EFS)
Progression-free survival (PFS)

LAPIS Trial Design

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

Find a Location

Who is running the clinical trial?

FibroGenLead Sponsor
57 Previous Clinical Trials
15,020 Total Patients Enrolled

Media Library

FOLFIRINOX (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03941093 — Phase 3
Pancreatic Cancer Research Study Groups: Arm A, Arm B
Pancreatic Cancer Clinical Trial 2023: FOLFIRINOX Highlights & Side Effects. Trial Name: NCT03941093 — Phase 3
FOLFIRINOX (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03941093 — Phase 3
Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT03941093 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most similar medical trials to the one being conducted involving Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX?

"The original Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX trial was completed in 1997 at City of Hope Comprehensive Cancer Center. Out of the 2771 total trials since then, 1603 are still actively recruiting patients. A large number of these studies are based out of Ann Arbor, Michigan."

Answered by AI

Have either of the following drug combinations been approved by the FDA: Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX?

"This medical treatment combination has been evaluated in Phase 3 clinical trials, meaning that there is some data suggesting that it is effective and multiple rounds of data supporting its safety. Our team at Power rates the safety of this combination as a 3 on a scale from 1 to 3."

Answered by AI

In how many different medical clinics is this clinical study being conducted today?

"With the majority of its operations based in University of Michigan (Ann Arbor, Michigan), Stony Brook University (Stony Brook, Texas) and Baylor College of Medicine (Houston, Connecticut), this clinical trial also has active outposts in 40 other locations."

Answered by AI

What illnesses or conditions is the Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX treatment regimen meant for?

"Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX are the most common treatments for malignant neoplasms. However, these medical interventions can also be effective against non-small cell lung carcinoma, rectal carcinoma, and colorectal carcinoma."

Answered by AI

Are we currently enrolling people for this trial?

"Unfortunately, this particular trial is not currently enrolling new patients. Although the posting was updated as recently as June 29th, 2022, the study is not seeking any more participants at this time. There are however, 2200 other trials which are actively recruiting right now."

Answered by AI

How many people have signed up to participate in this experiment?

"This particular clinical trial is not presently enrolling patients. It was first posted on 5/10/2019, and the most recent update occurred on 6/29/2022. However, if you expand your search to include other trials, there are 600 clinical trials actively recruiting participants with nonresectable pancreatic cancer and 1603 trials for Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX that are currently enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Virginia
What site did they apply to?
Hoag Memorial Presbyterian Hospital
Thomas Jefferson University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

My Oncologist, Dr. Suneentha Challagunda, suggested I search out clinical trials. I sent a promising new drug to kill the cancer out of Israel. Sadly they are many years from FDA approval so its seems I am reaching out to them for more information.
PatientReceived 2+ prior treatments
As, I completed my 6 Chemo cycles on 16th of July2023 and get a PET Scan done on 28th July2023 As 6 Chemo cycles are completed so further Chemo is discontinued as per advice from consultant (Dr.Anant Ramaswamy - Tata Memorial Hospital Mumbai) but continuing Immunotherapy(Durvalumap) for another 3 months (Although 5 cycles of Immuno also done by 14th of July, 6th one taken on 4th Aug and from now on will continue Immuno only at an interval of 28 days).
PatientReceived no prior treatments
~0 spots leftby Apr 2024