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Study of durvalumab or placebo administered with radiation therapy for patients with early stage non-small cell lung cancer Study of osimertinib administered after radiation therapy in patients with early stage non-small cell lung cancer harboring an EGFR mutation
EU CTIS ID: 2024-512667-31-00
What this study is testing
Applicable to main cohort: To assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS in patients with a subset of T1 to T3N0M0 NSCLC Applicable to osimertinib cohort: To assess the efficacy of osimertinib following SoC SBRT in patients with T1 to T3N0M0 in terms of 4-year PFS
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- (Applicable to both cohorts) Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling and analyses
- (Main cohort (durvalumab) specific) Life expectancy of at least 12 weeks
- (Main cohort (durvalumab) specific) Body weight >30 kg
- (Main cohort (durvalumab) specific) Adequate organ and marrow function required
- (Main cohort (durvalumab) specific) Pulmonary Function Testing within 16 weeks of randomization
- (Osimertinib cohort specific) Confirmation by local laboratory that the tumor harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
You likely can't join if
- (Applicable to both cohorts) Mixed small cell and non-small cell cancer
- (Osimertinib cohort specific) Patients with known or increased risk factor for QTc prolongation
- (Osimertinib cohort specific) Treatment with any of the following: Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation; Prior treatment with neoadjuvant or adjuvant EGFR TKI; Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4; Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
- (Osimertinib cohort specific) Any of the following cardiac criteria: Mean resting corrected QT interval >470 msec, obtained from 3 ECGs; Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.; Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval; Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- (Applicable to both cohorts) History of another primary malignancy with exceptions
- (Main cohort specific) Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
See the full eligibility criteria
Who can join
- (Applicable to both cohorts) Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling and analyses
- (Main cohort (durvalumab) specific) Life expectancy of at least 12 weeks
- (Main cohort (durvalumab) specific) Body weight >30 kg
- (Main cohort (durvalumab) specific) Adequate organ and marrow function required
- (Main cohort (durvalumab) specific) Pulmonary Function Testing within 16 weeks of randomization
- (Osimertinib cohort specific) Confirmation by local laboratory that the tumor harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
- (Osimertinib cohort specific) Adequate bone marrow reserve or organ function required
- (Applicable to both cohorts) Age ≥18 years
- (Applicable to both cohorts) Histologically or cytologically documented Stage I to II NSCLC, with clinical T1 to T3N0M0 Stage I/II disease and planned to receive definitive treatment with SBRT (Stereotactic Body Radiation Therapy). Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
- (Applicable to both cohorts) Planned SoC SBRT as definitive treatment
- (Applicable to both cohorts) World Health Organization (WHO)/ECOG PS of 0, 1, or 2
- (Applicable to both cohorts) Patients with central or peripheral lesions are eligible
- (Applicable to both cohorts) Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
- (Applicable to both cohorts) Staging studies must be done during screening (PET-CT within 10 weeks)
- (Applicable to both cohorts) Submission of available tumor tissue or cell block samples from FNA
What rules you out
- (Applicable to both cohorts) Mixed small cell and non-small cell cancer
- (Osimertinib cohort specific) Patients with known or increased risk factor for QTc prolongation
- (Osimertinib cohort specific) Treatment with any of the following: Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation; Prior treatment with neoadjuvant or adjuvant EGFR TKI; Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4; Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
- (Osimertinib cohort specific) Any of the following cardiac criteria: Mean resting corrected QT interval >470 msec, obtained from 3 ECGs; Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.; Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval; Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- (Applicable to both cohorts) History of another primary malignancy with exceptions
- (Main cohort specific) Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
- (Main cohort specific) History of allogeneic organ transplantation
- (Main cohort specific) History of active primary immunodeficiency or autoimmune disorders
- (Main cohort specific) History of non-infectious pneumonitis requiring steroids
- (Main cohort specific) Active infection including tuberculosis, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
- (Main cohort specific) Prior exposure to immune-mediate therapy
- (Osimertinib cohort specific) Patients currently receiving potent inducers of CYP3A4
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- Brazil
- China
- Russian Federation
- Turkey
- Australia
- Korea, Republic of
- United Kingdom
- Japan
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; Brazil; China; Russian Federation; Turkey and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.