Phase II umbrella study of novel anti-cancer agents in patients with NSCLC who progressed on an anti-PD-1/PD-L1 containing therapy.
- Conditions
- Patients with non-small cell lung cancer (NSCLC).
- Registration Number
- 2023-509004-15-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
To obtain an assessment of the efficacy of each treatment by evaluation of objective response rate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 172
At least 18 years of age at the time of signing the informed consent form.
Patient must have histologically or cytologically confirmed metastatic or locally advanced and recurrent NSCLC which is progressing.
Patients eligible for second- or later-line therapy, who must have received an anti PD 1/PD-L1 containing therapy and a platinum-doublet regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The patient must have had disease progression on a prior line of anti PD 1/PD-L1 therapy.
Suitable for a new tumour biopsy. For Module 10 and Module 11 only: If in agreement with the sponsor study physician, a patient may be exempt from a biopsy at pre-screening if a tumour tissue sample is obtained after progression on prior anti-PD-(L)1 therapy and ≤ 3 months prior to pre-screening; a tumour sample taken within the previous 24 months is acceptable if no such sample is available.
ECOG/WHO performance status of 0 to 1, and a minimum life expectancy of 12 weeks.
Patient must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed.
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
Patients whose tumour samples have targetable alterations in EGFR and/or ALK at initial diagnosis are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded.
Active or prior documented autoimmune or inflammatory disorders.
Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
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 study drugs or any of the study drug excipients or history of severe hypersensitivity reactions to other monoclonal antibodies.
Patient has spinal cord compression or symptomatic brain metastases.
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Patients may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors for the treatment of bone metastases.
History of active primary immunodeficiency.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Objective response rate (ORR) Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Objective response rate (ORR)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS). Overall Survival (OS).
Endpoints based on RECIST 1.1 including: Disease control rate (DCR) Endpoints based on RECIST 1.1 including: Disease control rate (DCR)
Endpoints based on RECIST 1.1 including: Best percentage change in tumour size Endpoints based on RECIST 1.1 including: Best percentage change in tumour size
Endpoints based on RECIST 1.1 including: Duration of response (DoR) Endpoints based on RECIST 1.1 including: Duration of response (DoR)
Endpoints based on RECIST 1.1 including: Progression free survival (PFS). Endpoints based on RECIST 1.1 including: Progression free survival (PFS).
Trial Locations
- Locations (10)
Hospital Clinic De Barcelona
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Virgen De La Macarena
🇪🇸Sevilla, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Institut Gustave Roussy
🇫🇷Villejuif, France
Institut Bergonie
🇫🇷Bordeaux, France
Centre Hospitalier Universitaire De Nantes
🇫🇷Saint Herblain, France
Stadt Wien Wiener Gesundheitsverbund
🇦🇹Vienna, Austria
Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Germany
Hospital Clinic De Barcelona🇪🇸Barcelona, SpainNoemí Reguart AransaySite contact034932275400NREGUART@clinic.cat