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Lung cancer breakthrough? new drug cocktail trial aims to boost surgery success

NCT ID NCT05061550

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study tests several drug combinations given before and after surgery for early-stage non-small cell lung cancer. About 630 participants will receive immunotherapy drugs like durvalumab along with chemotherapy or other targeted agents. The goal is to see if these combos can eliminate more cancer cells and improve long-term outcomes.

What this could mean

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

Active substance
Durvalumab, Oleclumab, Monalizumab, Dato-DXd, AZD0171, Volrustomig, Rilvegostomig, plus chemotherapy
What this could lead to
If successful, this could lead to better treatment options for early-stage lung cancer, potentially improving survival and reducing recurrence after surgery.
What could go wrong
This is an early Phase 2 trial, so results are not yet proven. The drug combinations may cause serious side effects, and not all participants may benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 630 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

May 2030

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 95 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: * Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB). * WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ and bone marrow function. * Provision of tumour samples (newly acquired or archival tumour tissue \[≤ 6 months old\]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status. * Adequate pulmonary function. Exclusion Criteria: * Participants with sensitising EGFR mutations or ALK translocations. * Participants with baseline PD-L1 expression status \<1% (Arms 6 and 7 only). * Active or prior documented autoimmune or inflammatory disorders. * Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement. * History of another primary malignancy. * Participants with small-cell lung cancer or mixed small-cell lung cancer. * History of active primary immunodeficiency. * History of non-infectious interstitial lung disease (ILD) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Participants who have preoperative radiotherapy treatment as part of their care plan. * Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour. * QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms. * Any medical contraindication to treatment with chemotherapy as listed in the local labelling. * Participants with moderate or severe cardiovascular disease. * Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. * Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions. * Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT (T cell immunoreceptor with Ig and ITIM domains), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded. * Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions. * Active or uncontrolled infections including HBA, HBV, HCV, and HIV.

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    82 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • Research Site

    WITHDRAWN

    Oakland, California, 94611, United States

  • Research Site

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Research Site

    COMPLETED

    Stuart, Florida, 34994, United States

  • Research Site

    COMPLETED

    Gainesville, Georgia, 30501, United States

  • Research Site

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Research Site

    WITHDRAWN

    Baltimore, Maryland, 21201, United States

  • Research Site

    RECRUITING

    Baltimore, Maryland, 21231, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    COMPLETED

    Saint Louis Park, Minnesota, 55426, United States

  • Research Site

    RECRUITING

    Omaha, Nebraska, 68124, United States

  • Research Site

    RECRUITING

    Buffalo, New York, 14263, United States

  • Research Site

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Research Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Research Site

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Research Site

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Research Site

    WITHDRAWN

    Nashville, Tennessee, 37203, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77090, United States

  • Research Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Research Site

    RECRUITING

    Edmonds, Washington, 98026, United States

  • Research Site

    RECRUITING

    Seattle, Washington, 98104, United States

  • Research Site

    RECRUITING

    Ghent, 9000, Belgium

  • Research Site

    COMPLETED

    Ghent, 9000, Belgium

  • Research Site

    RECRUITING

    Roeselare, 8800, Belgium

  • Research Site

    COMPLETED

    Edmonton, Alberta, T6G 1Z2, Canada

  • Research Site

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H2W 1S6, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Research Site

    RECRUITING

    Avignon, 84902, France

  • Research Site

    WITHDRAWN

    Bobigny, 93009, France

  • Research Site

    RECRUITING

    Bordeaux, 33076, France

  • Research Site

    RECRUITING

    Limoges, 83000, France

  • Research Site

    RECRUITING

    Rennes, 35000, France

  • Research Site

    RECRUITING

    Rouen, 76031, France

  • Research Site

    RECRUITING

    Suresnes, 92150, France

  • Research Site

    RECRUITING

    Toulon, 83000, France

  • Research Site

    RECRUITING

    Kecskemét, 6000, Hungary

  • Research Site

    RECRUITING

    Székesfehérvár, 8000, Hungary

  • Research Site

    COMPLETED

    Tatabánya, 2800, Hungary

  • Research Site

    RECRUITING

    Törökbálint, 2045, Hungary

  • Research Site

    RECRUITING

    Dublin, D07 R2WY, Ireland

  • Research Site

    RECRUITING

    Dublin, D08 NHY1, Ireland

  • Research Site

    RECRUITING

    Dublin, D09 V2N0, Ireland

  • Research Site

    RECRUITING

    Galway, H91 YR71, Ireland

  • Research Site

    RECRUITING

    Aviano, 33081, Italy

  • Research Site

    RECRUITING

    Brescia, 25123, Italy

  • Research Site

    WITHDRAWN

    Catanzaro, 88100, Italy

  • Research Site

    RECRUITING

    Florence, 50134, Italy

  • Research Site

    RECRUITING

    Genova, 16100, Italy

  • Research Site

    RECRUITING

    Meldola, 47014, Italy

  • Research Site

    RECRUITING

    Milan, 20162, Italy

  • Research Site

    RECRUITING

    Monza, 20900, Italy

  • Research Site

    RECRUITING

    Padova, 35128, Italy

  • Research Site

    RECRUITING

    Perugia, 06156, Italy

  • Research Site

    RECRUITING

    Pisa, 56124, Italy

  • Research Site

    RECRUITING

    Roma, 00144, Italy

  • Research Site

    RECRUITING

    Rozzano, 20089, Italy

  • Research Site

    RECRUITING

    Lisbon, 1099-023, Portugal

  • Research Site

    RECRUITING

    Lisbon, 1169-050, Portugal

  • Research Site

    RECRUITING

    Lisbon, 1400-038, Portugal

  • Research Site

    RECRUITING

    Lisbon, 1500-650, Portugal

  • Research Site

    WITHDRAWN

    Porto, 4099-001, Portugal

  • Research Site

    COMPLETED

    Porto, 4100-180, Portugal

  • Research Site

    RECRUITING

    Porto, 4200-072, Portugal

  • Research Site

    COMPLETED

    Busan, 48108, South Korea

  • Research Site

    WITHDRAWN

    Chungcheongbuk-do, 28644, South Korea

  • Research Site

    RECRUITING

    Seongnam-si, 13496, South Korea

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 05505, South Korea

  • Research Site

    RECRUITING

    Suwon, 16247, South Korea

  • Research Site

    RECRUITING

    Suwon, 440-746, South Korea

  • Research Site

    RECRUITING

    A Coruña, 15006, Spain

  • Research Site

    RECRUITING

    Alicante, 03010, Spain

  • Research Site

    RECRUITING

    Barcelona, 08036, Spain

  • Research Site

    RECRUITING

    Barcelona, 8035, Spain

  • Research Site

    RECRUITING

    Córdoba, 14004, Spain

  • Research Site

    RECRUITING

    Madrid, 28040, Spain

  • Research Site

    RECRUITING

    Majadahonda, 28250, Spain

  • Research Site

    RECRUITING

    Málaga, 29010, Spain

  • Research Site

    RECRUITING

    Reus, 43204, Spain

  • Research Site

    RECRUITING

    Seville, 41009, Spain

  • Research Site

    RECRUITING

    Terrassa, 08221, Spain

  • Research Site

    RECRUITING

    Valencia, 46010, Spain

  • Research Site

    RECRUITING

    Liuying, 736, Taiwan

  • Research Site

    RECRUITING

    New Taipei City, 235, Taiwan

  • Research Site

    RECRUITING

    Tainan, 70403, Taiwan

  • Research Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Research Site

    RECRUITING

    Taipei, 11217, Taiwan

  • Research Site

    RECRUITING

    Ankara, 06010, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Ankara, 06500, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Istanbul, 34722, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Izmir, 35575, Turkey (Türkiye)

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