Lung Cancer Clinical Trial
Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy
Summary
This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.
Full Description
This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on an anti-programmed cell death-1/anti-programmed cell death ligand 1 (anti-PD-1/PD-L1) containing therapy. This study is modular in design, consisting of a number of treatment cohorts, allowing evaluation of the efficacy, safety, and tolerability of multiple treatment arms. There is currently no established therapy for patients who have received immune checkpoint inhibitors and platinum-doublet therapies, and novel treatments are urgently needed.
This protocol has a modular design, with the potential for future treatment arms to be added via protocol amendment.
Eligibility Criteria
Inclusion criteria:
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 antiPD1/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 antiPD1/PD-L1 therapy.
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.
Exclusion Criteria:
Patients whose tumour samples have targetable alterations in EGFR and/or ALK 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-Î’ ligand (RANKL) inhibitors for the treatment of bone metastases.
history of active primary immunodeficiency
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There are 48 Locations for this study
Duarte California, 91010, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Washington District of Columbia, 20016, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21224, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55455, United States
Saint Louis Missouri, 63110, United States
New York New York, 10032, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37212, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Wien , 1140, Austria
Wien , 1210, Austria
Edmonton Alberta, T6G 1, Canada
Brampton Ontario, L2P 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 3, Canada
Bordeaux , 33076, France
Nantes Cedex 1 , 44093, France
Paris , 75877, France
Villejuif , 94800, France
Berlin , 12203, Germany
Esslingen a.N. , 73730, Germany
Großhansdorf , 22927, Germany
Heidelberg , 69126, Germany
Köln , 50924, Germany
Haifa , 31096, Israel
Kfar Saba , 95847, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52656, Israel
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Sevilla , 41009, Spain
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