Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study

STATUS

Recruiting
End date

May 1, 2032
participants needed

100
sponsor

Oslo University Hospital

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Updated on 19 February 2024

See if I qualify

cancer

hysterectomy

platelet count

absolute neutrophil count

serum pregnancy test

metastasis

neutrophil count

lung cancer

liver metastasis

durvalumab

oophorectomy

chemoradiotherapy

urine test

serum bilirubin

bilateral oophorectomy

experimental drug

stage iii non-small cell lung cancer

pd-l1

pet/ct scan

secondary malignant neoplasm of liver

serum bilirubin level

medi4736

excisional biopsy

non-small cell lung cancer

small cell lung cancer

durvalumab injection

Summary

The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation.

The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.

Description

This is an open, multinational, phase 2 trial to investigate the Properties of cancer cells before, during and after treatment with the investigational study drug durvalumab in patients with locally advanced non-small celled lung cancer (NSCLC). Both patients with high and low PD-L1 expression are allowed to participate. Durvalumab (PD-L1 inhibitor) will be administered after a period with standardtreatment with chemotherapy and radiationtherapy (chemoradiotherapy) for around 7 weeks. After maximum 5 weeks break after chemoradiotherapy, durvalumab will be given in the same dose to all patients for up to 12 months. The follow-up include a safety follow-up for up to five years, followed by a survival follow-up for up to a total of ten years.

The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.

Details

Condition	Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Cancer, Non Small Cell Lung Cancer Stage III, NSCLC, Stage III
Age	18years - 100years
Treatment	Durvalumab Injection
Clinical Study Identifier	NCT04392505
Sponsor	Oslo University Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Locally-advanced, unresectable, stage III NSCLC (including PET-CT and MRI-brain in the diagnostic work-up)
	Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
	Diagnostic biopsy with PD-L1 <1% in 50 patients PD-L1 1% in 50 patients
	Adequate core or excisional biopsy for tumor assessment
	Age > 18 years at time of study entry
	Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
	Life expectancy of at least 12 weeks
	Body weight >30 kg
	Adequate normal organ and marrow function as defined below
	Haemoglobin 9.0 g/dL - Absolute neutrophil count (ANC) 1.5 x (> 1500 per mm3)
	Platelet count 100 x 109/L (>75,000 per mm3)
	Serum bilirubin 1.5 x institutional upper limit of normal (ULN)
	AST (SGOT)/ALT (SGPT) 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be 5x ULN
	Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
	Males
	Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
	Females
	Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
	Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause
	Women of childbearing potential (WOCBP) should have a negative urine or serum pregnancy within 7 days prior to receiving the firs dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A woman is considered as WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
	WOCBP should use an adequate method to avoid pregnancy
	males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) / the time required for the investigational drug to undergo five half-lives
	Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Exclusion Criteria
	Non-small cell lung cancer disease suitable for curative surgery
	Significant cardiac, pulmonary or other medical illness that would limit activity or survival
	Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study during the last 2 weeks
	Any concurrent chemotherapy, Investigational Product (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
	Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
	History of allogenic organ transplantation
	Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this
	criterion
	Patients with vitiligo or alopecia
	Patients with hypothyroidism (e.g., following Hashimoto syndrome) stableon hormone replacement
	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
	Patients with celiac disease controlled by diet alone
	Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic 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 j. History of another primary malignancy except for
	Malignancy treated with curative intent and with no known active disease 5 years before the first dose of IP and of low potential risk for recurrence
	Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
	Adequately treated carcinoma in situ without evidence of disease k. History of active primary immunodeficiency or medical condition requiring high doses (>30 mg prednisolone daily) of systemic steroids or other forms of immunosuppressive therapy
	Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), and hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
	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 (e.g., intra articular injection)
	Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
	Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
	Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last 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 from screening to 90 days after the last dose of durvalumab monotherapy
	Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
	Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
	Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements

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cancer

hysterectomy

platelet count

absolute neutrophil count

bilateral oophorectomy

experimental drug

stage iii non-small cell lung cancer

pd-l1

pet/ct scan

secondary malignant neoplasm of liver

serum bilirubin level

medi4736

excisional biopsy

non-small cell lung cancer

small cell lung cancer

durvalumab injection

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Study Definition

Wikipedia

Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study