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Soluble LAG-3 Fusion Protein
Eftilagimod Alpha + Pembrolizumab for Non-Small Cell Lung Cancer (TACTI-002 Trial)
Phase 2
Waitlist Available
Research Sponsored by Immutep S.A.S.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1
Part C (2nd line PD-X naive HNSCC): Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies after failure of prior platinum-based therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 month
Awards & highlights
TACTI-002 Trial Summary
This trial will test if eftilagimod alpha can help pembrolizumab work better against non-small cell lung carcinoma and head and neck carcinoma.
Who is the study for?
This trial is for adults with certain types of lung or head and neck cancer. For lung cancer, it's for those who haven't had treatment before or whose first treatment didn't work. For head and neck cancer, it's after the first treatment fails. Participants must be in good physical condition (ECOG 0-1) and not have specific genetic mutations, recent high-dose lung radiation, multiple past treatments, active brain metastases without stability post-treatment, or a history of severe immune-related side effects from similar drugs.Check my eligibility
What is being tested?
The trial tests combining Eftilagimod alpha with Pembrolizumab to see if they're safe together and work well against non-small cell lung carcinoma (NSCLC) that can't be surgically removed or has spread elsewhere (metastatic), as well as recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, fatigue, nausea, skin rash, itching, joint pain; more serious ones could involve the immune system attacking normal organs like lungs or intestines.
TACTI-002 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My throat cancer has returned or spread and cannot be cured with surgery or other treatments.
Select...
My NSCLC didn't respond to initial treatments including PD-1/PD-L1 inhibitors.
TACTI-002 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 42 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of objective response rate (ORR) according to iRECIST
Secondary outcome measures
Disease control rate according to iRECIST and RECIST 1.1
Duration of (serious) adverse events
Duration of responses according to iRECIST and RECIST 1.1
+8 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
TACTI-002 Trial Design
3Treatment groups
Experimental Treatment
Group I: HNSCCExperimental Treatment2 Interventions
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Group II: 2nd line NSCLCExperimental Treatment2 Interventions
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Group III: 1st line NSCLCExperimental Treatment2 Interventions
Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).
Pembrolizumab: 200 mg every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Immutep S.A.S.Lead Sponsor
11 Previous Clinical Trials
1,502 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,382 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on high doses of steroids or other immune-weakening medicines.I have stage IV NSCLC and have completed systemic therapy more than 6 months before my metastatic diagnosis.I am fully active or can carry out light work.I had severe side effects from previous cancer immunotherapy and had to stop it.My NSCLC is in the early stages and can be treated with surgery or radiation.I have head and neck cancer and haven't received specific immune treatments before.I have had cancer treatment or been in a trial within the last 4 weeks.I have stable brain metastases and haven't needed steroids for 14 days.I have advanced lung cancer not treatable with EGFR/ALK therapy and haven't received systemic therapy for it.I have had more than one chemotherapy treatment for my advanced lung cancer.My throat cancer has returned or spread and cannot be cured with surgery or other treatments.I have fluid buildup in my abdomen or around my lungs and it's causing symptoms.My NSCLC is positive for EGFR mutation or ALK gene fusion.My NSCLC didn't respond to initial treatments including PD-1/PD-L1 inhibitors.I have had more than one treatment for my recurring or spreading head and neck cancer.I have not had lung radiation over 30Gy in the last 6 months.I had lung radiation of more than 30Gy within the last 6 months.My head or neck cancer can be treated with the goal of curing it.
Research Study Groups:
This trial has the following groups:- Group 1: 2nd line NSCLC
- Group 2: HNSCC
- Group 3: 1st line NSCLC
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.
What is the current capacity of participants for this trial?
"Unfortunately, this clinical trial has ceased accepting new candidates. It was initially posted on February 18th 2019 and last updated June 10th 2022. However, there are 1936 studies recruiting for oral squamous cell carcinoma patients and 963 trials actively seeking individuals for Eftilagimod alpha testing."
Answered by AI
In what scenarios is Eftilagimod alpha frequently utilized?
"Eftilagimod alpha is a therapeutic agent that can help treat conditions like advanced melanoma, microsatellite instability high colorectal cancer, and disease progression following chemotherapeutic treatment."
Answered by AI
Has Eftilagimod alpha been tested in any other research studies?
"Presently, 963 clinical trials are investigating the effectiveness of Eftilagimod alpha. Of these trials, 122 have achieved Phase 3 status while 35732 different sites run various studies for this medication. Houston is one of the major cities running research into Eftilagimod alpha."
Answered by AI
Is the study currently open for enrollment?
"Contrarily to what is reported on clinicaltrials.gov, this research initiative is not currently seeking patients for its trial. The study was first posted in February of 2019 and last edited in June 2022, although there are many other trials actively recruiting right now with 2,899 open positions available."
Answered by AI
What health risks have been identified with Eftilagimod alpha?
"Due to the limited efficacy data available from its Phase 2 clinical trial, Eftilagimod alpha's safety rating is conservatively estimated as a 2 on our scale."
Answered by AI
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