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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

Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC resectable (Stage IIA to Stage IIIA) disease (according to Version 8 of IASLC Staging Manual in Thoracic Oncology 2016)

WHO Performance Status or Eastern Cooperative Oncology Group of 0 or 1

Must not have

Previous study drugs (durvalumab, IPH5201) assignment in the present study

History of another primary malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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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My body weight is more than 35 kg.

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My lung function tests show I have at least 40% of the normal capacity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been given durvalumab or IPH5201 in this study.

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I have had another type of cancer.

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I have moderate or severe heart disease.

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I have previously received immunotherapy.

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I do not have any severe illnesses that my doctors are still trying to get under control.

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I have or had an autoimmune or inflammatory disorder.

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My lung cancer is of the small-cell or mixed small-cell type.

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My cancer has specific changes in the EGFR gene or ALK gene.

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I cannot have chemotherapy due to health reasons.

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I am receiving radiotherapy before surgery as part of my treatment.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events (AEs) and serious adverse events (SAEs)

Pathological Complete Response (pCR)

Secondary study objectives

Anti-study drug antibodies (ADA)

Disease Free Survival (DFS)

Event-Free Survival (EFS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 14Eligibility criteria met