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Taxane Chemotherapy
DoceRamPem for Lung Cancer (DoceRamPem Trial)
Phase 2
Recruiting
Led By Badi El Osta, MD, FACP
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have progressed on a platinum-based chemotherapy and any FDA-approved PD-1 or PD-L1 immune checkpoint inhibitors, either given sequentially or in combination
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
DoceRamPem Trial Summary
This trial is testing a combination of immunotherapy, chemotherapy, and an anti-VEGF therapy to treat NSCLC patients who did not respond to other FDA-approved treatments.
Who is the study for?
This trial is for adults with non-small cell lung cancer (NSCLC) who didn't respond to platinum-based chemo and PD-1/PD-L1 inhibitors. They should have manageable heart conditions, adequate blood counts, measurable disease, agree to contraception use, and not be pregnant or breastfeeding. Prior cancers are okay if they don't affect this study's safety or results. Participants need a life expectancy over 12 weeks and must have recovered from previous cancer treatments.Check my eligibility
What is being tested?
The trial tests combining Pembrolizumab (an immunotherapy), Ramucirumab (blocks blood vessel growth in tumors), and Docetaxel (a chemotherapy drug). It aims to see if this mix is safer and works better than the current standard care after NSCLC patients' disease progresses following specific prior treatments.See study design
What are the potential side effects?
Possible side effects include immune system reactions that can affect organs, infusion-related symptoms, fatigue, nausea, low blood cell counts increasing infection risk. There may also be risks of bleeding due to Ramucirumab affecting blood vessels.
DoceRamPem Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened after treatment with platinum chemotherapy and PD-1/PD-L1 inhibitors.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am not pregnant, not breastfeeding, and follow birth control guidelines.
Select...
My lung cancer diagnosis was confirmed through tissue examination.
Select...
My heart function is classified as class 2B or better according to NYHA.
Select...
Side effects from my last cancer treatment are mild or gone.
Select...
My kidney function, measured by creatinine levels or clearance, is within the normal range.
DoceRamPem Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-month progression-free survival (PFS) rate
Secondary outcome measures
Incidence of adverse events
Overall response rate
Overall survival (OS)
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
DoceRamPem Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (docetaxel, ramucirumab, pembrolizumab)Experimental Treatment3 Interventions
Patients receive docetaxel IV over 60 minutes, ramucirumab IV over 60 minutes, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Pembrolizumab
2017
Completed Phase 2
~2010
Ramucirumab
2017
Completed Phase 3
~5050
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,655 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,813 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,630 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has worsened after treatment with platinum chemotherapy and PD-1/PD-L1 inhibitors.I haven't had cancer treatment or experimental drugs in the last 4 weeks.Your liver enzyme levels are within a certain range, or slightly higher if you have cancer that has spread to the liver.I stopped using immune therapy due to side effects treated with steroids.I am fully active or restricted in physically strenuous activity but can do light work.Your bilirubin levels in the blood are within a certain range.You have a tumor that can be measured using specific guidelines.You have a severe allergic reaction to pembrolizumab or any of its ingredients.You have been diagnosed with mental health or substance abuse issues.I have been treated with docetaxel or ramucirumab before.I am not pregnant, not breastfeeding, and follow birth control guidelines.I haven't had any major bleeding or blood clot events in the last 3 months.I have a history of Hepatitis B or an active Hepatitis C infection.My lung cancer diagnosis was confirmed through tissue examination.I agree to use birth control and not donate sperm for 120 days after my last treatment dose.I have an autoimmune disease treated with medication in the last 2 years.I finished palliative radiotherapy more than a week ago.My heart function is classified as class 2B or better according to NYHA.I do not have any unmanaged ongoing illnesses.I have not received a live vaccine in the last 30 days.I have had or currently have lung inflammation that needed steroids.I had radiotherapy less than a week before starting the study treatment.You have high levels of protein in your urine.You have a normal level of a type of white blood cells called neutrophils.You have a platelet count of at least 100,000 per microliter of blood.I am currently being treated for an infection.I have had serious heart problems in the last 6 months.I have another cancer type, but it won't affect this trial's treatment.Your hemoglobin level is at least 9.0 g/dL or 5.6 mmol/L.If you are a woman of childbearing potential and have a positive urine pregnancy test within 3 days before starting treatment.Side effects from my last cancer treatment are mild or gone.I have an immune system disorder or have been on steroids or other immune-weakening drugs recently.I have brain metastasis causing symptoms.Your doctor thinks you will live for at least 12 more weeks.I have been diagnosed with HIV.My kidney function, measured by creatinine levels or clearance, is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (docetaxel, ramucirumab, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any other experimental protocols involved Docetaxel?
"Currently, there are 1290 active Docetaxel trials with 244 of those in the critical Phase 3 stage. Most of these studies take place at New Lambton Heights in New South Wales; however, across 56263 different centres worldwide research is being conducted on this drug."
Answered by AI
What ailments is Docetaxel typically utilized to treat?
"Docetaxel is a viable option for patients with malignant neoplasms, unresectable melanomas and high microsatellite instability."
Answered by AI
Are there any opportunities for individuals to partake in this experiment?
"Affirmative. The clinicaltrials.gov database indicates that this trial, first published on June 5th 2020, is actively recruiting participants - 41 in total from a single location."
Answered by AI
How perilous are the ramifications of Docetaxel usage?
"There is evidence that Docetaxel has a level of safety, so it was assigned an estimation of 2. However, since this is only Phase 2 testing, there are no results yet indicating efficacy."
Answered by AI
What is the cap for enrollees in this experiment?
"Indeed, the information on clinicaltrials.gov points to an ongoing recruitment process for this study. The initial announcement of the trial was made on June 5th 2020 and it has since been updated as recently as October 19th 2022 with 41 participants needed from a single location."
Answered by AI
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