CompletedPhase 1NCT03421353
Official study title

AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer

Study summary

This is a phase Ib/II, open-label multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 plus durvalumab alone or in combination with chemotherapy in patients with advanced, solid tumours and subsequently in patients with non-small-cell lung cancer (NSCLC)

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAZD9150 and Durvalumab

Plus 5 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 21, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
AstraZeneca
Interventions being studied
Drug: AZD9150; Drug: Durvalumab; Drug: Cisplatin; Drug: 5-Flourouracil; Drug: Carboplatin; Drug: Gemcitabine; Drug: Nab-paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Subjects are eligible to be included in the study only if all of the following inclusion criteria and none of the

Reasons someone may not be able to joinExclusion criteria
  • apply. 1. Signed and dated informed consent. For inclusion in the optional pharmacogenetic research, patients must provide informed consent for the genetic sampling and analyses. 2. ≥ 18 years of age. 3. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Minimum life expectancy of 12 weeks 5. Part A of the study will include patients that have histological confirmation of a solid malignancy \[other than Hepatocellular Carcinoma (HCC)\] that is refractory to standard therapy or for which no standard of care regimen currently exists. 6. Part D of the study will include patients with histological confirmation of a solid malignancy (other than HCC) that are refractory to standard therapy of for which no standard of care regimen currently exists. 7. Willing to undergo mandatory biopsy at screening and on treatment. Part A only: the first 3 subjects in each arm are exempt from this requirement. Patients in Part D are exempt from this biopsy requirement. 8. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes that must have short axis ≥15 mm) with computerised tomography (CT) or magnetic resonance imaging (MRI) that is suitable for accurate repeated measurements. 9. Females should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
  • Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
  • Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinising hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
  • Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation. 10. Male patients must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 20 weeks after the last dose of study treatments.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteLafayette, Indiana
  • Research SiteOklahoma City, Oklahoma
  • Research SiteNashville, Tennessee
  • Research SiteDallas, Texas
  • Research SiteHouston, Texas
  • Research SiteFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2024. Always confirm current availability with the study team.

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