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New study tracks how gene mutations affect lung cancer treatment success

NCT ID NCT06494540

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study is following 600 people in Germany with a type of advanced lung cancer (non-squamous non-small cell) who are starting a three-drug treatment: tremelimumab, durvalumab, and platinum chemotherapy. Researchers want to see how well the treatment works in real life, especially for patients with certain genetic mutations (like KRAS, STK11, KEAP1, or TP53). The goal is to learn which patients might benefit most from this combination, helping doctors make better treatment decisions.

What this could mean

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

Active substance
tremelimumab, durvalumab, and platinum chemotherapy
What this could lead to
If successful, this could help doctors identify which lung cancer patients benefit most from this combination therapy based on their genetic profile.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection and real-world variability. It does not test a new treatment, only gathers data on existing use.

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.

Participants

About 600 people

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

Started

Jun 2024

Expected to finish

Dec 2029

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.

Who is studied

Adult patients (≥18 years) with a histologically or cytologically confirmed NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician), planned treatment initiation with TDC according to applicable Summary of product characteristics (SmPCs) within routine clinical practice and initiated molecular gene panel analysis (including KRAS, STK11, KEAP1, and TP53) as well as PD-L1 and TTF-1 expression analyses are eligible for enrolment. Eligible patients will be included into the study after and independently of the treating physician's treatment and diagnostic decisions but no later than 21 days after application of the first TDC treatment cycle.

Ages

18 to 120 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: * Aged ≥ 18 years * Decision to start first-line (1L) treatment with TDC according to the current SmPCs * Histologically or cytologically confirmed diagnosis of NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician) * No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) alterations * Molecular Next Generation Sequencing (NGS) panel as per institutional standard has been initiated (including the following genes: KRAS, STK11, KEAP1, and TP53) * TTF-1 expression analysis has been initiated * PD-L1 expression analysis has been initiated * Women of childbearing potential must use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab * Ability to understand the study concept * Provision of signed informed consent form in accordance with applicable local provisions Exclusion Criteria: * Current participation in interventional clinical trials * Contraindications according to current SmPCs * Any active tumor other than metastatic NSCLC\* * Mixed histology NSCLC with both adenocarcinoma and squamous cell carcinoma components (adenosquamous carcinoma or any mixed NSQ- squamous tumor), regardless of the predominant component * determined by investigator as likely to influence the prognosis or management of mNSCLC

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Conditions

The condition(s) this trial relates to.

hereditary sensory and autonomic neuropathy non-small cell lung carcinoma

As listed by the trial registrant

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

Non-squamous metastatic non-small-cell lung carcinoma

How to take part

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

  1. The places running it

    28 sites. 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

    Bad Homburg, Germany

  • Research Site

    RECRUITING

    Berlin, Germany

  • Research Site

    RECRUITING

    Bremen, Germany

  • Research Site

    WITHDRAWN

    Celle, Germany

  • Research Site

    RECRUITING

    Chemnitz, Germany

  • Research Site

    RECRUITING

    Cologne, Germany

  • Research Site

    RECRUITING

    Deggendorf, Germany

  • Research Site

    RECRUITING

    Frankfurt, Germany

  • Research Site

    RECRUITING

    Georgsmarienhütte, Germany

  • Research Site

    WITHDRAWN

    Gera, Germany

  • Research Site

    RECRUITING

    Goslar, Germany

  • Research Site

    RECRUITING

    Greifswald, Germany

  • Research Site

    RECRUITING

    Halle-Dolau, Germany

  • Research Site

    RECRUITING

    Hanover, Germany

  • Research Site

    RECRUITING

    Herne, Germany

  • Research Site

    RECRUITING

    Hösbach, Germany

  • Research Site

    RECRUITING

    Koblenz, Germany

  • Research Site

    RECRUITING

    Koln-Mehrheim, Germany

  • Research Site

    RECRUITING

    Mainz, Germany

  • Research Site

    RECRUITING

    Marburg, Germany

  • Research Site

    RECRUITING

    Münnerstadt, Germany

  • Research Site

    RECRUITING

    Neuss, Germany

  • Research Site

    RECRUITING

    Offenbach, Germany

  • Research Site

    RECRUITING

    Querfurt, Germany

  • Research Site

    RECRUITING

    Ravensburg, Germany

  • Research Site

    RECRUITING

    Rüsselsheim am Main, Germany

  • Research Site

    RECRUITING

    Treuenbrietzen, Germany

  • Research Site

    RECRUITING

    Ulm, Germany

  • Research Site

    RECRUITING

    Wiesbaden, Germany

  • Research Site

    RECRUITING

    Zwickau, Germany