MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).

Study summary

This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or metastatic NSCLC subjects

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGefitinib and MEDI4736

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 4, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?MedImmune LLC

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: MedImmune LLC
Interventions being studied: Drug: Gefitinib; Drug: MEDI4736

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key 1. Provision of signed and dated, written informed consent 2. Male or female aged 18 years and older. 3. Subjects must have a. In the escalation phase, locally advanced or metastatic NSCLC subjects who have either failed to respond or relapsed following any line of standard treatment, were unable to tolerate, or were not eligible for standard treatment b. In the expansion phase, histologically or cytologically confirmed locally advanced or metastatic NSCLC that is EGFR mutation positive, naïve to EGFR TKI therapy, and sensitive to EGFR TKIs therapy 4. a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For Expansion Phase: At least one measurable lesion. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
For Japan Escalation - the same as the global escalation I/E criteria except patients must be EGFR mutation positive Key

Reasons someone may not be able to joinExclusion criteria

1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. 2. Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment 3. Inadequate bone marrow reserve or organ function

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Research SiteTampa, Florida
Research SiteHouston, Texas
Research SiteSeattle, Washington
Research SiteChūōku
Research SiteMatsuyama
Research SiteSeoul
Research SiteSeoul

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 4, 2022. Always confirm current availability with the study team.

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