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Small Molecule Inhibitor

Combination Therapy for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by MedImmune LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Weight ≥ 35 kg

Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFRm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose (within 90 minutes prior to start of infusion) and postdose (1, 2, and 4 hours) on days 1 and 29

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of new combination therapies for people with EGFRm NSCLC.

Who is the study for?

This trial is for adults over 18 with advanced non-small cell lung cancer that has a specific mutation (EGFRm). Participants must have tried one EGFR inhibitor and can't be T790M positive. They should weigh at least 35 kg, be fairly active (ECOG of 0 or 1), and not have used certain medications recently. People with untreated brain metastases, recent heart issues, or autoimmune diseases in the last three years cannot join.Check my eligibility

What is being tested?

The study tests new combinations of drugs: Oleclumab with Osimertinib for those who've had one prior therapy, and Oleclumab with AZD4635 for those who've had two to four therapies. It aims to assess safety, tolerability, and how well these combos work against advanced EGFRm NSCLC.See study design

What are the potential side effects?

Potential side effects may include immune system reactions leading to inflammation in various organs, infusion-related responses like fever or chills during drug administration, fatigue from treatment burden on the body's energy resources, digestive disturbances such as nausea or diarrhea due to gastrointestinal tract involvement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 35 kilograms.

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My lung cancer is advanced or has spread, and tests show it has EGFR mutations.

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I am fully active or can carry out light work.

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I've had one treatment with an EGFR inhibitor and do not have the T790M mutation.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on days 1 and 57

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on days 1 and 57

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on days 1 and 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2

Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs in Parts 1 and 2

Number of Participants With Dose-limiting Toxicities (DLTs) in Part 1

+3 more

Secondary outcome measures

Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X)

Cmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X)

Duration of Response (DoR) Per RECIST v 1.1 for Parts 1 and 2

+10 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Oleclumab Dose 2 + Osimertinib Dose 1Experimental Treatment2 Interventions

In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 2 Q2W and oral osimertinib Dose 1 QD. In Part 2 (dose-expansion), participants (including participants dosed at the RP2D in Part 1) will receive IV oleclumab Dose 2 Q2W and oral osimertinib Dose 1 QD until documentation of disease progression, intolerable toxicity, or development of other reason for treatment discontinuation, whichever occurs first.

Group II: Oleclumab Dose 2 + AZD4635 Dose 2Experimental Treatment2 Interventions

In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.

Group III: Oleclumab Dose 1 + Osimertinib Dose 1Experimental Treatment2 Interventions

In Part 1 (dose-escalation), participants will receive intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).

Group IV: Oleclumab Dose 1 + AZD4635 Dose 2Experimental Treatment2 Interventions

In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.

Group V: Oleclumab Dose 1 + AZD4635 Dose 1Experimental Treatment2 Interventions

In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oleclumab

2015

Completed Phase 2

~880