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Monoclonal Antibodies
IPH5201 + Durvalumab + Chemotherapy for Lung Cancer
Phase 2
Recruiting
Research Sponsored by Innate Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing potential should use an acceptable method of contraception from the time of screening throughout the total duration of the study
Adequate organ and marrow function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years.
Awards & highlights
Study Summary
This trial will test a combo of drugs for early-stage NSCLC to see if it can safely and effectively treat the disease.
Who is the study for?
This trial is for patients with early-stage (II to IIIA) non-small cell lung cancer that can be surgically removed. They must have proper organ function, not be pregnant, and agree to use contraception. Excluded are those with small-cell lung cancer, certain genetic mutations, autoimmune diseases, another primary malignancy, or severe cardiovascular disease.Check my eligibility
What is being tested?
The study tests the combination of IPH5201 and durvalumab with standard chemotherapy before surgery (neoadjuvant therapy), followed by the same drugs after surgery (adjuvant therapy). It aims to evaluate safety and effectiveness in untreated NSCLC patients eligible for tumor removal.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue from treatment burden on the body's resources, digestive disturbances due to drug impact on gut health, blood abnormalities caused by bone marrow suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using birth control during the study period.
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My organs and bone marrow are working well.
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I have newly diagnosed, untreated NSCLC that can be surgically removed.
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I can carry out all my daily activities without help.
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I can provide recent tumor samples to check for specific cancer markers.
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My body weight is more than 35 kg.
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My surgery plan includes lobectomy, sleeve resection, or bilobectomy.
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My lung function tests show I have at least 40% of the normal capacity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events (AEs) and serious adverse events (SAEs)
Pathological Complete Response (pCR)
Secondary outcome measures
Anti-study drug antibodies (ADA)
Disease Free Survival (DFS)
Event-Free Survival (EFS)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: IPH5201 + durvalumab + standard chemotherapyExperimental Treatment1 Intervention
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy.
Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.
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Who is running the clinical trial?
Innate PharmaLead Sponsor
27 Previous Clinical Trials
2,971 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I have previously been given durvalumab or IPH5201 in this study.I have had another type of cancer.You are expected to live for at least 12 more weeks.I am not on any cancer treatments but may be on hormone therapy for other reasons.I am using birth control during the study period.I have not taken immunosuppressive drugs in the last 14 days.My organs and bone marrow are working well.I have not had any major surgery within the last 30 days.I have moderate or severe heart disease.Your heart's electrical activity (QTc interval) is too long. If it's too long, we'll need to check it a few more times before deciding if you can participate.I have previously received immunotherapy.I have newly diagnosed, untreated NSCLC that can be surgically removed.I can carry out all my daily activities without help.I do not have any severe illnesses that my doctors are still trying to get under control.I have or had an autoimmune or inflammatory disorder.I am not pregnant or breastfeeding and agree to use birth control during and up to 6 months after the study.I am not participating in the DNA genetics research part of the study.My lung cancer is of the small-cell or mixed small-cell type.You have had an organ transplant from someone else.My cancer has specific changes in the EGFR gene or ALK gene.I may need surgery to remove part or all of my lung to treat my cancer.I can provide recent tumor samples to check for specific cancer markers.I cannot have chemotherapy due to health reasons.You need to provide tumor samples for additional research.My body weight is more than 35 kg.My surgery plan includes lobectomy, sleeve resection, or bilobectomy.You have a history of ongoing problems with your immune system.Women who can have babies need to have a negative pregnancy test.My lung function tests show I have at least 40% of the normal capacity.I do not have an active infection like TB, hepatitis B, or hepatitis C.I haven't had any blood clots or strokes in the last 6 months.I am receiving radiotherapy before surgery as part of my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: IPH5201 + durvalumab + standard chemotherapy
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.
How many participants are being included in the research endeavor?
"Affirmative. The details provided on clinicaltrials.gov verify that this research trial, which was first publicized in February 1st 2023, is actively soliciting participants. Approximately 70 subjects must be enlisted from two distinct centres of care."
Answered by AI
Is this research initiative currently accepting new participants?
"According to the clinicaltrials.gov website, this medical trial is currently open for enrollment and was initially announced on February 1st 2023 with its last update taking place on February 23rd of that same year."
Answered by AI
Has the combination of IPH5201, durvalumab and standard chemotherapy been endorsed by the FDA?
"Our team's evaluation graded the safety of IPH5201 + durvalumab + standard chemotherapy at 2 out of 3 due to only Phase 2 trial results being available and no existing evidence for efficacy."
Answered by AI
What are the distinct ambitions of this clinical trial?
"Innate Pharma, the trial sponsor of this medical study, has indicated that Adverse events (AEs) and Serious adverse Events (SAEs) will be measured as primary outcomes over a 16 week period post-first dose. Additionally, Disease Free Survival (DFS), Surgical Resection, and Anti-study Drug Antibodies (ADA) are noted as secondary outcomes for measurement purposes."
Answered by AI
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