New combo shows promise for Tough-to-Treat lung cancer
NCT ID NCT05941897
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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39 people
The number who actually took part.
- Started
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Jun 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Research Site
Moscow, 111123, Russia
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Research Site
Moscow, 115478, Russia
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Research Site
Moscow, 115533, Russia
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Research Site
Moscow, 125284, Russia
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Research Site
Moscow, 143423, Russia
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Research Site
Nizhny Novgorod, 603126, Russia
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Research Site
Saint Petersburg, 197758, Russia
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Research Site
Saint Petersburg, 198255, Russia
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