NCT04624204 : A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Systemic therapy,Treatment | LungLung,Small Cell Lung Cancer

Trial Overview Read MoreRead more

This phase III trial is evaluating the survival benefit from using concurrent chemoradiation with and without targeted therapy for the treatment of small cell lung cancer.
 

This trial is treating patients with small cell lung cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Commercial Sponsor

Merck

Summary

Eligible patients will be randomised into one of three groups. In Group A, participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus 200mg of pembrolizumab every 3 weeks concurrently with standard thoracic radiotherapy. This will be followed by 9 cycles of pembrolizumab (400 mg every 6 weeks) plus an olaparib matching placebo twice daily for 12 months or until specific discontinuation criteria are met. Group B participants will also receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus 200mg pembrolizumab every 3 weeks concurrently with standard thoracic radiotherapy. This will be followed by 9 cycles of pembrolizumab (400 mg every 6 weeks) plus 300mg olaparib 300 mg twice daily for 12 months or until specific discontinuation criteria are met. Participants in Group C will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum), this time with a pembrolizumab-placebo (saline) every 3 weeks concurrently with standard thoracic radiotherapy. This will be followed by 9 cycles of pembrolizumab-placebo (saline) every 6-weeks, plus a olaparib matching placebo for 12 months or until specific discontinuation criteria are met.

Recruiting Hospitals Read MoreRead more

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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