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New combo shows promise for Tough-to-Treat lung cancer

NCT ID NCT05941897

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 2 times

Summary

This phase 2 trial tests a combination of two drugs—ceralasertib (a pill) and durvalumab (an infusion)—in 39 adults with advanced or metastatic non-small cell lung cancer that has worsened after standard treatments like immunotherapy and chemotherapy. The main goal is to see if the combination can shrink tumors. Researchers will also track how long any response lasts and how quickly it occurs.

What this could mean

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

Active substance
ceralasertib and durvalumab
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced lung cancer who have run out of standard therapies.
What could go wrong
This is a small, early-phase trial with only 39 participants and no comparison group, so results may not be conclusive. The combination may cause side effects or fail to shrink tumors.

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

39 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Jan 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: * Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology. * Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status. * Documented radiological PD whilst on or after receiving the most recent treatment regimen. * Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC. * Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1. * Adequate organ function and marrow reserve. * Body weight \> 30 kg and no cancer-associated cachexia. Exclusion Criteria: * Participant with mixed SCLC and NSCLC histology. * Brain metastases or spinal cord compression unless the participant is stable and off steroids. * Persistent toxicities (CTCAE Grade \> 2) caused by previous anticancer therapy. * Active or prior documented autoimmune or inflammatory disorders. * History of leptomeningeal carcinomatosis. * Participants who have received more than one line of prior anti-PD-(L)1. * Participants must not have experienced a toxicity that led to discontinuation of the prior anti-PD(L)1 therapy. * Participants must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy. * Participants must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged. * Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting. * As judged by the investigator, any evidence of medical condition, which, in the investigator's opinion, makes it undesirable for the participant to participate in the study. * Participants who have received a prior ATR inhibitor. * Diagnosis of ataxia telangiectasia.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Research Site

    Moscow, 111123, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 115533, Russia

  • Research Site

    Moscow, 125284, Russia

  • Research Site

    Moscow, 143423, Russia

  • Research Site

    Nizhny Novgorod, 603126, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Saint Petersburg, 198255, Russia

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