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New cocktail therapy hopes to tackle tough lung cancer

NCT ID NCT03381274

Disease control Sponsor: MedImmune LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This early-stage trial tests two new drug combinations in people with advanced EGFR-mutated non-small cell lung cancer whose previous treatments have stopped working. The study combines a biologic (oleclumab) with either the targeted drug osimertinib or another experimental drug (AZD4635). The main goals are to check safety and see if the tumors shrink. About 43 adults are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oleclumab (a biologic) combined with either osimertinib (Tagrisso) or AZD4635 (a drug)
What this could lead to
If successful, this could point toward new combination treatments that help control advanced EGFR-mutated lung cancer after other therapies stop working.
What could go wrong
This is an early-phase trial with only 43 participants, so results may not apply to all patients. The combinations may cause serious side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

43 people

The number who actually took part.

Started

May 2018

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 101 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 3. Weight ≥ 35 kg 4. Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFRm * For Arm A (Oleclumab + Osimertinib arms): must have received 1 prior line of therapy with an EGFR tyrosine kinase inhibitor (TKI) and confirmed T790M negative * For Arm B (Oleclumab + AZD4635 arms): must have received at least 2 but not more than 4 prior lines of therapy. Exclusion Criteria: 1. Receipt of an EGFR TKI within 14 days of the first dose of study treatment 2. Receipt of any conventional or investigational anticancer therapy not otherwise specified within 21 days of the planned first dose 3. Prior receipt of any investigational immunotherapy. Participants may have received agents that have local health authority approval for the disease indication 4. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed. 5. Participants with a history of venous thrombosis within the past 3 months 6. Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 6 months 7. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment 8. Other invasive malignancy within 2 years 9. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression 10. Current or prior use of immunosuppressive medication within 14 days prior to the first dose Additional Exclusion Criteria for Arm A 1. Concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of cytochrome P (CYP) 3A4 2. Participants has a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD 3. Participants requires continuous supplemental oxygen for any reason Additional Exclusion Criteria for Arm B 1. Herbal preparations/medications are not allowed throughout the study 2. History of seizures excluding those that occurred due to previously untreated CNS metastasis

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    San Francisco, California, 94143, United States

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    New Haven, Connecticut, 06510, United States

  • Research Site

    Atlanta, Georgia, 30322, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Baltimore, Maryland, 21224, United States

  • Research Site

    New York, New York, 10032, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Taichung, 40705, Taiwan

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