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Active not recruitingPHASE3INTERVENTIONAL

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

This study is for people with a type of lung cancer called Small Cell Lung Cancer, specifically when it's caught at an early stage. You would be considered if you've recently finished a strong combination of chemotherapy and radiotherapy, and your cancer hasn't worsened. The research aims to find out if new medicines, Durvalumab and Tremelimumab, either alone or together, can help prevent the cancer from returning or growing after this initial treatment. Some participants will receive a dummy drug (placebo) to help compare the new treatments fairly. It's a key step in understanding if these drugs can offer a longer, healthier life for people with this condition.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
730
Start
27 Sep 2018
Estimated completion
23 Oct 2026

Results

Results from this study

Posted August 2025

Results have been published for this study.

Primary outcome
Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1
PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective disease progression (PD) or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.
Full results on the registry

What is this study about?

This research is a 'Phase 3' clinical trial, which means it's a very important stage where doctors want to confirm if a new treatment is truly better than what's currently available or no further treatment. It focuses on a specific type of lung cancer called 'Small Cell Lung Cancer' (SCLC) when it's found at an early stage, called 'limited-stage'.

Participants in this study have already received a powerful combination of chemotherapy and radiotherapy, and importantly, their cancer has not grown or spread after this initial treatment. The main goal here is to see if giving additional drugs—Durvalumab,Tremelimumab, or a combination of both—after this first strong treatment can help keep the cancer from coming back. Some people will receive a 'placebo', which looks like the study drug but contains no active medicine. This is a standard way to ensure that any improvements seen are definitely due to the study drugs and not other factors.

Finding new ways to keep cancer from returning after initial treatment is very important. This study hopes to improve the long-term outlook for people with limited-stage SCLC by exploring whether these particular drugs can act as a 'consolidation treatment' – meaning they strengthen the success of the first treatment. The results from studies like this help shape future standard treatments for cancer patients.

Key takeaways

  • Tests new drugs (Durvalumab, Tremelimumab) for early-stage Small Cell Lung Cancer.
  • For people who finished chemo and radiotherapy, and cancer hasn't worsened.
  • Aims to prevent cancer return after initial strong treatment.
  • Compares new drugs against each other and a dummy drug (placebo).
  • Participation involves regular hospital visits for monitoring.

Who may be eligible?

To join this study, you would need to have been diagnosed with 'limited-stage small cell lung cancer' (meaning it hasn't spread widely). You must have recently completed a course of chemotherapy along with radiotherapy (within 1 to 42 days before starting the study treatment), and your cancer must not have worsened after these treatments. The chemotherapy you received must have included platinum and etoposide, and the radiotherapy would have been given over about 3 to 6 weeks.

There are also some general health requirements: you should have a good level of physical fitness (a score of 0 or 1 on a scale called ECOG, which your doctor can explain) and a life expectancy of at least 12 weeks. Sometimes, a preventive brain radiation (PCI) might be given, and if so, this needs to have been completed before the study drug starts.

However, you wouldn't be able to join if your cancer has already spread widely ('extensive-stage SCLC'), or if you have certain other health conditions like active autoimmune diseases, uncontrolled illnesses like severe lung problems, or ongoing infections such as tuberculosis, HIV, or hepatitis. This study is not for people who had their chemotherapy and radiotherapy separated, meaning they didn't happen at the same time.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have I been diagnosed with limited-stage small cell lung cancer?
  2. Have I recently finished combined chemotherapy and radiotherapy for my cancer?
  3. Has my cancer not grown or spread after my initial treatments?
  4. Do I feel generally well, with a good level of fitness?
  5. Do I have any serious ongoing infections or autoimmune conditions?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to receive one of the study drugs or a placebo, like a sugar pill, without you or your doctor knowing which one initially. You'll need to visit the hospital regularly for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. These visits will be more frequent at the start and then become less often over time.

The treatment itself will involve receiving medication, which might be given through an IV drip or as tablets, depending on the specific drug. The total duration of the investigational treatment will vary for each participant, but there will be a follow-up period, possibly for several years, even after you stop receiving the study drug. This is to keep an eye on your long-term health and the lasting effects of the treatment. Your participation involves attending all scheduled appointments and reporting any changes in your health to your study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new and possibly more effective treatment that could help prevent your cancer from returning or growing. However, there's also a chance you might receive a placebo and not benefit directly from the study drug. All medications, including the ones in this study, have potential risks and side effects, which the study team will explain in detail. You'll be closely monitored for any reactions. It's very important to remember that joining this study is completely your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (183)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Tucson, United States
  • Research Site
    Verified postcode
    Santa Rosa, United States
  • Research Site
    Verified postcode
    New Haven, United States
  • Research Site
    Verified postcode
    Fort Myers, United States
  • Research Site
    Verified postcode
    Orange City, United States
  • Research Site
    Verified postcode
    St. Petersburg, United States
  • Research Site
    Verified postcode
    Marietta, United States
  • Research Site
    Verified postcode
    Hines, United States
  • Research Site
    Verified postcode
    Fort Wayne, United States
  • Research Site
    Verified postcode
    Muncie, United States
  • Research Site
    Verified postcode
    Lexington, United States
  • Research Site
    Verified postcode
    Annapolis, United States

Common questions

What is 'Limited Stage Small Cell Lung Cancer'?

It's a type of lung cancer that hasn't spread widely in your body, usually only affecting one side of your chest and nearby lymph nodes.

What is 'consolidation treatment'?

It's an extra treatment given after your initial strong treatments (like chemo and radiotherapy) to help make sure the cancer doesn't come back or grow.

What's the difference between Durvalumab and Tremelimumab?

These are both types of 'immunotherapy' drugs. They work by helping your body's own immune system fight cancer, but they target different pathways. The study is looking at them alone or together.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the study drug but contains no active medicine. It helps researchers fairly compare the active drugs.

Will I know if I'm getting the drug or placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know which treatment you are receiving until the study is over, or if there's a medical need to find out.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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