Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    410
  • sponsor
    AstraZeneca
Updated on 14 May 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (0.0 mi away) Contact
+54 other location
durvalumab
stage iv non-small cell lung cancer
recurrent non-small cell lung cancer

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.

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.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment AZD9150, durvalumab, olaparib, AZD6738, Cediranib, Vistusertib, oleclumab, Trastuzumab deruxtecan, AZD6738 (ceralasertib)
Clinical Study IdentifierNCT03334617
SponsorAstraZeneca
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

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- ligand (RANKL) inhibitors for the treatment of bone metastases
history of active primary immunodeficiency
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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