A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With … (NCT05170204) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)
United States, Australia, Belgium68 participantsStarted 2022-11-01
Plain-language summary
This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) NSCLC staging system.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (All Cohorts):
* Body weight ≥ 30 kilograms (kg) at screening
* Willingness and ability to use the electronic device(s) or application(s) for the electronic patient-reported outcome (PRO)
* Whole-body positron emission tomography/computed tomography scan (PET/CT) (from the base of skull to mid-thighs) for the purposes of staging, performed prior and within 42 days for Cohort A2 (ROS1 positive) and 50 days for Cohort A1 (ALK positive) of the first dose of concurrent chemoradiotherapy (cCRT) or sequential chemoradiotherapy (sCRT)
* Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
* Prior receipt of at least two prior cycles of platinum-based chemotherapy given cCRT; or at least two prior cycles of platinum-based chemotherapy given prior to radiotherapy (sCRT)
* The RT component in the cCRT or sCRT must have been at a total dose of radiation of 60 (+/-10%) Gy (54 Gy to 66 Gy) administered by intensity-modulated radiotherapy (preferred) or three dimension (3D)-conforming technique
* No disease progression during or following platinum-based cCRT or sCRT
* Life expectancy ≥ 12 weeks
* Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen
* Tumor programmed death-ligand 1 (PD-L1) status (TC score \< 1% vs. ≥ 1% vs. unknown) as determined using the VENTANA PD-L1 IHC SP263 assay (preferred) or the Dako PD-L1 IHC 22C3 pharmDx assay
* Eas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial that is active but no longer enrolling new participants, does that mean enrollment is closed, and if so, are there similar trials currently open that I might be eligible for?
2This trial is studying locally advanced, unresectable Stage III non-small cell lung cancer specifically — does my diagnosis and staging actually match that profile, and would my doctor consider me a candidate for this type of treatment approach?
3The trial's main goal is measuring how long patients go without their cancer progressing, called progression-free survival — how does that measure compare to what I might expect from the current standard of care for Stage III NSCLC, like chemoradiation followed by durvalumab?
4Since multiple different therapies are being tested in separate cohorts in this study, can my doctor explain what types of treatments are involved and whether any of those approaches would be relevant to my specific situation even outside of a trial?
5Given that this trial is no longer recruiting, should we be looking at the standard treatment pathway now, and at what point might results from this trial start influencing treatment decisions for patients like me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival (PFS), as Determined by Blinded Independent Central Review (BICR) per Response Evaluation Criterial in Solid Tumors Version 1.1 (RECIST V1.1)
Timeframe: From randomization to the first documented disease progression or death from any cause, whichever occurs first (up to 3 years)