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

  • STATUS
    Recruiting
  • End date
    May 10, 2024
  • participants needed
    724
  • sponsor
    AstraZeneca
Updated on 6 June 2021
prophylactic cranial irradiation
etoposide
chemoradiotherapy
cancer chemotherapy
limited stage small cell lung cancer

Summary

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Details
Condition Small Cell Lung Cancer, sclc, small cell carcinoma, small cell carcinoma of the lung
Treatment Placebo, tremelimumab, durvalumab
Clinical Study IdentifierNCT03703297
SponsorAstraZeneca
Last Modified on6 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III)
Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules
PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP
Have not progressed following definitive concurrent chemoradiation 5 .Life
expectancy 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment

Exclusion Criteria

Extensive-stage SCLC
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness, including but not limited to interstitial lung disease
Active infection including tuberculosis, HIV, hepatitis B and C
Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note