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Prevymis
JOURNAL ONKOLOGIE – STUDIE
HUDSON

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

Rekrutierend

NCT-Nummer:
NCT03334617

Studienbeginn:
Dezember 2017

Letztes Update:
01.04.2021

Wirkstoff:
Durvalumab, AZD9150, AZD6738, Vistusertib, Olaparib, Oleclumab, Trastuzumab Deruxtecan, cediranib, AZD6738 (ceralasertib)

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
AstraZeneca

Collaborator:
-

Studienleiter

John Heymach, M.D, Ph.D
Principal Investigator
The University of Texas MD Anderson Cancer Center

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 41)

Research Site
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
50924 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
60637 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
55455 Minneapolis
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
15232 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
22031 Fairfax
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
49100 Petah Tikva
IsraelAktiv, nicht rekrutierend» Google-Maps
Research Site
5265601 Ramat Gan
IsraelAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Assessment of the efficacy of each treatment by evaluation of objective response rate (Time Frame - 12 weeks):
Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Objective response rate (ORR)



Secondary outcome:

1. Disease control rate (DCR) using RECIST 1.1 assessment for the anti-tumour activity of each therapy. (Time Frame - Through to study completion, up to 3.5 years.):
Assessment of the anti-tumour activity of each therapy.

2. Best percentage change in tumour size using RECIST 1.1 assessment for the anti-tumour activity of each therapy (Time Frame - Through to study completion, up to 3.5 years.):
Assessment of the anti-tumour activity of each therapy.

3. Duration of response (DoR) using RECIST 1.1 assessment for the anti-tumour activity of each therapy. (Time Frame - Through to study completion, up to 3.5 years):
Assessment of the anti-tumour activity of each therapy.

4. Progression free survival (PFS) using RECIST 1.1 assessment for the anti-tumour activity of each therapy. (Time Frame - Through to study completion, up to 3.5 years.):
Assessment of the anti-tumour activity of each therapy.

5. Overall surival (OS) (Time Frame - Through to study completion, up to 4.5 years.):
Assessment of the anti-tumour activity of each therapy.

Studien-Arme

  • Experimental: Durvalumab + olaparib
    Durvalumab given in combination with olaparib .
  • Experimental: Durvalumab + AZD9150
    Durvalumab given in combination with AZD9150.
  • Experimental: Durvalumab + AZD6738
    Durvalumab given in combination with AZD6738.
  • Experimental: Durvalumab + vistusertib
    Durvalumab given in combination with Vistusertib (AZD2014).
  • Experimental: Durvalumab + Oleclumab
    Durvalumab given in combination with Oleclumab
  • Experimental: durvalumab + trastuzumab deruxtecan
    durvalumab given in combination with trastuzumab deruxtecan (DS-8201a)
  • Experimental: durvalumab + cediranib
    durvalumab given in combination with cediranib (AZD2171)
  • Experimental: AZD6738 (ceralasertib) monotherapy
    AZD6738 (ceralasertib) given as monotherapy
  • Experimental: durvalumab & AZD6738 (ceralasertib)
    durvalumab given in combination with AZD6738 (D15-D28)

Geprüfte Regime

  • Durvalumab:
    Durvalumab given IV at 1500 mg Q4W ±2 days
  • AZD9150:
    AZD9150 given IV at 200mg every other day of a 1-week lead-in period followed by QW
  • AZD6738:
    AZD6738 given orally at 240mg twice daily in Cycle 0 Days 1-7, followed by 7 days on treatment in each cycle between Days 22-28
  • Vistusertib:
    Vistusertib (AZD2014) given orally at a dose of 125 mg BD on an intermittent dosing schedule of 2 days on, 5 days off
  • Olaparib:
    Olaparib (AZD2281) given orally at 300 mg BD
  • Oleclumab:
    Oleclumab given at dose level 1 for 2 cycles and then dose level 2 thereafter
  • trastuzumab deruxtecan:
    Durvalumab given IV at 1120mg Q3W ±2 days for Module 6 only & trastuzumab deruxtecan given at 5.4 mg/kg via IV infusion Q3W ±2 days
  • cediranib:
    cediranib given orally at 20 mg tablets on an intermittent schedule (5 days on, 2 days off), starting on C1D1
  • AZD6738 (ceralasertib):
    AZD6738 given at 240 mg twice daily for 14 days on treatment in each 28-day cycle, between Days 1 and 14.
  • AZD6738 (ceralasertib):
    AZD6738 given orally at 240mg twice daily for 14 days in each 28 day cycle (starting from Cycle 1) between Days 15-28

Quelle: ClinicalTrials.gov


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