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New drug cocktail shows early promise for tough lung cancer

NCT ID NCT04612751

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called datopotamab deruxtecan (Dato-DXd) combined with immunotherapy, with or without chemotherapy, in 155 people with advanced non-small cell lung cancer. The goal is to see if the combination is safe and shows signs of shrinking tumors. It is not yet known if this approach will work better than current treatments.

What this could mean

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

Active substance
Datopotamab deruxtecan (Dato-DXd) combined with immunotherapy drugs (durvalumab, rilvegostomig, or volrustomig) and sometimes carboplatin
What this could lead to
If this works, it could point toward a new combination treatment for advanced lung cancer that may shrink tumors and delay progression.
What could go wrong
This is a very early (Phase 1b) study focused on safety, not yet proven to work. Side effects from combining these drugs could be significant, and the benefit may be limited or not confirmed in larger trials.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

155 people

The number who actually took part.

Started

Feb 2021

Expected to finish

May 2027

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 years and older

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: * Participant ≥18 years old on the day of signing the ICF (local regulatory requirement to consent should be followed). * Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC, without EGFR or ALK genomic alterations (testing not required for participants with documented squamous histology) and no known genomic alterations in other actionable driver kinases with approved therapies. Participants whose tumors harbor KRAS mutations are eligible for this study. * For Cohorts 1 to 4, participants must be treatment-naïve or have received and radiologically progressed after only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors for advanced or metastatic NSCLC. For Cohorts 4a, 5 to 11, and 14, participants must be treatment-naïve for advanced or metastatic NSCLC. For Cohorts 12 to 13, participants must be CPI acquired resistant after 1 or 2 prior lines of systemic therapy for advanced or metastatic NSCLC, of which 1 should have contained an approved anti-PD-1/PD L1. Cohort 4a will enroll participants whose tumors have squamous histology only; Cohorts 5 Part 2A and Part 2B as well as Cohorts 12 and 13 will enroll participants whose tumors have non-squamous histology only. * Willing and able to undergo a mandatory tumor biopsy. A tumor biopsy that was recently collected (within 3 months of screening) after completion of the most recent anticancer treatment regimen may be substituted for the biopsy collected during screening. For Cohorts 12 and 13, a tumor sample taken ≤24 months prior to screening is acceptable. * Has measurable disease per RECIST1.1 within 28 days prior to Cycle 1 Day 1 * Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 at screening * Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 day 1 * For Cohorts 5 to 14 only: Documented IHC PD-L1 expression per analytically validated Ventana PD-L1 (SP263) IHC assay, 22C3 PharmDx assay, or 28-8 PharmDx assay Exclusion Criteria: * Active or prior documented autoimmune or inflammatory disorders * Uncontrolled or significant cardiac disease * History of another primary malignancy with exceptions * active or uncontrolled hepatitis B or C virus or uncontrolled HIV infection * spinal cord compression or clinically active CNS metastases * History of (non-infectious) ILD/pneumonitis that required steroids * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * Clinically significant corneal disease

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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.

Advanced or metastatic NSCLC

Contacts and locations

Locations

  • Research Site

    Taipei, 100, Taiwan

  • Research Site

    Taipei, 110, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taoyuan, 00333, Taiwan

  • Research Site

    Adana, 01060, Turkey (Türkiye)

  • Research Site

    Ankara, 06800, Turkey (Türkiye)

  • Research Site

    Ankara, 6200, Turkey (Türkiye)

  • Research Site

    Istanbul, 34010, Turkey (Türkiye)

  • Research Site

    Izmir, 35330, Turkey (Türkiye)

  • Research Site

    Hsinchu, 300, Taiwan

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    Santa Ana, California, 92705, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Hackensack, New Jersey, 07601, United States

  • Research Site

    Cleveland, Ohio, 44106, United States

  • Research Site

    Philadelphia, Pennsylvania, 19111, United States

  • Research Site

    Dallas, Texas, 75230, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Hasselt, 3500, Belgium

  • Research Site

    Roeselare, 8800, Belgium

  • Research Site

    Aviano, 33081, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Roma, 00144, Italy

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Lodz, 93-338, Poland

  • Research Site

    Lublin, 20-090, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    A Coruña, 15005, Spain

  • Research Site

    Badalona, 08916, Spain

  • Research Site

    Barcelona, 8036, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    Madrid, 28050, Spain

  • Research Site

    Seville, 41015, Spain

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 704, Taiwan

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