Skip to main content

Table 1 Complete list of inclusion and exclusion criteria

From: Thoracic radiotherapy plus Durvalumab in elderly and/or frail NSCLC stage III patients unfit for chemotherapy - employing optimized (hypofractionated) radiotherapy to foster durvalumab efficacy: study protocol of the TRADE-hypo trial

Inclusion criteria
• Fully-informed written consent and locally required authorization obtained from the patient/ legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Age ≥ 18 years.
• Histologically documented diagnosis of unresectable stage III NSCLC.
• Non-feasibility of sequential chemo−/radiotherapy as determined by the site’s multi-disciplinary tumor board; if there is no tumor board, then this decision will be made by the investigator in consultation with a radiation oncologist, if the investigator is not a radiation oncologist; or by the investigator in consultation with an oncologist, if the investigator is not an oncologist.
• Fulfills at least one of the following criteria:
ECOG 2
ECOG 1 and CCI ≥ 1
Age ≥ 70 years
• Must have a life expectancy of at least 12 weeks.
• FEV1 ≥ 40% of predicted
• DLCO ≥40% of predicted
• FVC or VC ≥ 70% of predicted
• At least one measurable site of disease as defined by RECIST 1.1 criteria.
• Adequate bone marrow, renal, and hepatic function
• Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
• The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
Exclusion criteria
• Concurrent enrollment in another clinical study or enrollment within 21 days prior to first dose of treatment, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study.
• Prior immunotherapy or use of other investigational agents.
• History or current radiology suggestive of interstitial lung disease.
• Oxygen-dependent medical condition.
• Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment.
• Prior thoracic radiotherapy within the past 5 years before the first dose of study drug.
• Major surgery within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery. Local non-major surgery for palliative intent is acceptable.
• Active or prior documented autoimmune or inflammatory disorders, with the following exceptions: Patients with vitiligo or alopecia, patients with hypothyroidism stable on hormone replacement, or any chronic skin condition that does not require systemic therapy. Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
• Active, uncontrolled inflammatory bowel disease. Patients in stable remission for more than 1 year may be included.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, interstitial lung disease, gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
• History of another primary malignancy except for a malignancy that has been treated with curative intent and was not active for ≥5 years before the first dose of IP and of low potential risk for recurrence or adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease or adequately treated carcinoma in situ without evidence of disease
• History of leptomeningeal carcinomatosis
• History of active primary immunodeficiency
• History of allogenic organ or tissue transplantation.
• Clinical diagnosis of active tuberculosis.
• Positive testing for hepatitis B virus surface antigen or hepatitis C virus RNA indicating acute or chronic infection or for human immunodeficiency virus.
• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections; systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions
• Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
• Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.
• Known allergy or hypersensitivity to any of the IPs or any of the constituents of the product.
• Any co-existing medical condition that in the investigator’s judgement will substantially increase the risk associated with the patient’s participation in the study.
• Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
• Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
\