A multicentre, Phase II, single-arm, interventional study of neoadjuvant durvalumab and platinum-based chemotherapy (CT), followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with resectable or borderline resectable stage IIB-IIIB Nonsmall Cell Lung Cancer (NSCLC)
- Conditions
- on-small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503357-35-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
Participant must be = 18 years, at the time of screening., The participant should be deemed to have adequate cardiac and lung function, according to a multidisciplinary assessment. A pre- or postbronchodilator FEV1 of 1.0 L and >40% postoperative predicted value. Use of these cut-off values to assess candidacy for resection should be guided by the results of cardiopulmonary exercise testing as outlined in the ESMO guidelines on pre-treatment risk assessment. Both an FEV1 and a DLCO test are required for assessing lung function prior to resection, Minimum body weight of 30 kg., Male and/or female. Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies, Negative pregnancy test (serum) for FOCBP, Female participants must be for 1 year or more postmenopausal, surgically sterile, or using at least one highly effective method of contraception (a highly effective method of contraception isdefined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) (a) Females < 50 years old are considered postmenopausal if they have been amenorrhoeic for 12 months or more prior to enrolment following cessation of exogenous hormonal treatment and folliclestimulating hormone (FSH) levels in the postmenopausal range. (b) Females = 50 years old are considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment, or had radiation-induced menopause with last menses > 1 year ago, or had chemotherapy-induced menopause with last menses > 1 year ago. (c) Female participants of child-bearing potential must agree to use at least one highly effective method of birth control. They should have been stable on their chosen method of birth control for a minimum of 3 months prior to enrolment (screening), while receiving study intervention, SoC CT or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information/SmPC relating to contraception and the time limit for such precautions for SoC agents. Cessation of birth controlafter this point should be discussed with a responsible physician. (d) Non-sterilised male partners of a female participant of child-bearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening their female partner, while their female partner is receiving study intervention, SoC CT or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information/SmPC relating to contraception and the time limit for such precautions for SoC agents. (e) Periodic abstinence, as well as the rhythm and withdrawal methods are not acceptable methods of birth control., Male participants who intend to be sexually active with a female partner of child-bearing potential must be surgically sterile or using an acceptable method of contraception (see Appendix G) from the time of screening , while receiving study intervention, SoC CT or CRT and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information/SmPC relating to contraception and the time limit for such precautions for SoC agents to prevent pregnancy in a partner. Male participants must not donate or bank sperm duri
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diseases, active infection, active ILD/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea, psychiatric illness/social situations), chronic diverticulitis or previous complicated diverticulosis, or history of allogenic organ transplant, which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol, History of active primary immunodeficiency, Investigator judgement of one or more of the following: - Mean resting corrected QT interval > 470 ms, obtained from triplicate ECGs performed at screening. - History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP. - Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden cardiac death under 40 years of age in first-degree relatives, Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, antiPD-1, anti-PD-L1 and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines., 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 (eg, 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 or as an anti-emetic (eg, computed tomography scan premedication), Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention, Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention, Any medical contraindication to treatment with platinumbased doublet CT, as listed in the local labellin, Previous treatment in the present study or a previous durvalumab clinical study regardless of treatment arm assignment, Participation in another clinical study with a study intervention administered in the last 4 weeks prior to first dose of durvalumab or 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, Participants with a known hypersensitivity to durvalumab or any excipients of the product(s)., Unresectable NSCLC confirmed by MDT evaluation at diagnosis: - Deemed unresectable NSCLC by multidisciplinary evaluation -Any stage IIIC, Participants whose planned surgery at enrolment includes wedge resections, Participants contraindicated for surgical intervention due to comorbid conditions, Existence of more than one primary tumour, such as: mixed small cell and NSCLC histology; synchronous or metachronous tumours that could represent distinct primary tumours, History of another primary malignancy except for malignancy treated with curative-intent with no known active disease = 5 years before the first dose of study intervention and of low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone pot
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