← Back to Search

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

Must not have

Receipt of an EGFR TKI within 14 days of the first dose of study treatment

Participants with a history of venous thrombosis within the past 3 months

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

No Placebo-Only Group

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.

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.

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

Select...

I weigh at least 35 kilograms.

Select...

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

Select...

I am fully active or can carry out light work.

Select...

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

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I have taken an EGFR inhibitor within the last 14 days.

Select...

I have had a blood clot in the last 3 months.

Select...

I am taking or cannot stop taking drugs or supplements that affect liver enzyme CYP3A4.

Select...

I am not taking any herbal medications.

Select...

I have not had a heart attack, mini-stroke, or stroke in the last 6 months.

Select...

My cancer has spread to my brain or spinal cord and hasn't been treated.

Select...

I have a history of lung conditions that needed steroid treatment.

Select...

I need to use extra oxygen all the time.

Select...

I haven't had cancer treatment in the last 3 weeks.

Select...

I have not had another type of cancer in the last 2 years.

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

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

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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

AZD4635

2016

Completed Phase 2

~440