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.

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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.

View Eligibility Criteria

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-Β ligand (RANKL) inhibitors for the treatment of bone metastases.
history of active primary immunodeficiency

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

530

Study ID:

NCT03334617

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 48 Locations for this study

See Locations Near You

Research Site
Duarte California, 91010, United States
Research Site
Fullerton California, 92835, United States
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La Jolla California, 92093, United States
Research Site
Los Angeles California, 90095, United States
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Washington District of Columbia, 20016, United States
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Chicago Illinois, 60637, United States
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Baltimore Maryland, 21224, United States
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Baltimore Maryland, 21287, United States
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Boston Massachusetts, 02215, United States
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Boston Massachusetts, 02215, United States
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Detroit Michigan, 48201, United States
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Minneapolis Minnesota, 55455, United States
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Saint Louis Missouri, 63110, United States
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New York New York, 10032, United States
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Philadelphia Pennsylvania, 19111, United States
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Pittsburgh Pennsylvania, 15232, United States
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Nashville Tennessee, 37203, United States
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Nashville Tennessee, 37212, United States
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Houston Texas, 77030, United States
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Fairfax Virginia, 22031, United States
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Innsbruck , 6020, Austria
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Salzburg , 5020, Austria
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Wien , 1140, Austria
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Wien , 1210, Austria
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Edmonton Alberta, T6G 1, Canada
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Brampton Ontario, L2P 2, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H2X 3, Canada
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Bordeaux , 33076, France
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Nantes Cedex 1 , 44093, France
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Paris , 75877, France
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Villejuif , 94800, France
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Berlin , 12203, Germany
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Esslingen a.N. , 73730, Germany
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Großhansdorf , 22927, Germany
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Heidelberg , 69126, Germany
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Köln , 50924, Germany
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Haifa , 31096, Israel
Research Site
Kfar Saba , 95847, Israel
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Petah Tikva , 49100, Israel
Research Site
Ramat Gan , 52656, Israel
Research Site
Seoul , 03080, Korea, Republic of
Research Site
Seoul , 05505, Korea, Republic of
Research Site
Seoul , 135-7, Korea, Republic of
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Barcelona , 08036, Spain
Research Site
Madrid , 28007, Spain
Research Site
Madrid , 28034, Spain
Research Site
Sevilla , 41009, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

530

Study ID:

NCT03334617

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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