Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:

Description

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.

Official Title

An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients With Non-Small Cell Lung Cancer, Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON).

Details

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.

Keywords

Non-Small Cell Lung Cancer NSCLC anti-PD-1/PD-L1 umbrella study Durvalumab MEDI4736 Olaparib AZD2281 AZD9150 AZD6738 Vistusertib AZD2014 Oleclumab MEDI9447 Lung Neoplasms Carcinoma, Non-Small-Cell Lung Antibodies, Monoclonal Durvalumab + olaparib Durvalumab + AZD9150 Durvalumab + AZD6738 Durvalumab + vistusertib Durvalumab + Oleclumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 disease progression on a prior anti-PD-1/PD-L1 containing therapy.
  • Suitable for a new tumour biopsy.
  • 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.

You CAN'T join if...

  • 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 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.
  • 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.

Locations

  • Research Site accepting new patients
    Los Angeles California 90095 United States
  • Research Site accepting new patients
    La Jolla California 92093 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT03334617
Phase
Phase 2
Study Type
Interventional
Last Updated