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 mutatio
- Conditions
- Main cohort: Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer Osimertinib cohort: Open-label, Single arm for patients with unresected stage I/II, lymph done negative NSCLC harboring a sensitizing EGFR mutationMedDRA version: 21.1Level: LLTClassification code: 10029514Term: Non-small cell lung cancer NOS Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-512667-31-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 690
(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
(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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method