Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT05298423 : Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Radiotherapy<br/>TrialTypeRadiotherapy
Trial

ThreePhase Three

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Radiotherapy,Systemic therapy | LungNon-Small Cell Lung Cancer

Trial Overview Read MoreRead more

This phase III study is evaluating whether immunotherapy (pembrolizumab/vibostolimab) in combination with chemoradiotherapy followed by further treatment with immunotherapy is more effective than treatment with chemoradiotherapy followed by a different type of immunotherapy (durvalumab), in people with non-small cell lung cancer.
 

This trial is treating patients with unresectable, locally advanced, stage III non-small cell lung cancer.

This is a systemic and radiation therapy trial.

You may be able to join this trial if:

  • Your cancer has 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

Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC

Commercial Sponsor

Merck

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, for the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray [Gy] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants then receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. In the Active Comparator Arm, for the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following cCRT, participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.

Recruiting Hospitals Read MoreRead more

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9231 3167

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.

Next