Study of AZD2811 + Durvalumab in ES-SCLC

  • STATUS
    Recruiting
  • End date
    Mar 11, 2024
  • participants needed
    100
  • sponsor
    AstraZeneca
Updated on 12 September 2021
maintenance therapy
etoposide
carboplatin
cancer chemotherapy
platinum-based chemotherapy

Summary

A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer

Description

Primary objective of this study is to evaluate the efficacy of AZD2811 and durvalumab in patients who have not progressed following induction therapy with platinum-based chemotherapy combined with durvalumab.

This is an open-label, single arm study. Patients will be treated in an induction phase with platinum-based induction therapy and durvalumab. At the end of this induction period, participants will be assessed for disease progression, per RECIST v1.1.

Participants who have not progressed per RECIST v1.1 at the end of the induction phase will roll over into the maintenance phase of the trial, where patients will commence AZD2811 and durvalumab combination.

Participants will be treated with AZD2811 and durvalumab as maintenance therapy until confirmed progressive disease, start of non-protocol defined anticancer therapy, unacceptable toxicity, or withdrawal of consent.

If study intervention is permanently discontinued, the participant will remain in the study to be evaluated for safety assessment, as well as for confirmed disease progression and for survival.

Targeted population are adult patients (aged 18 years) with histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC [T any, N any,M1 a/b]), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Patients must have WHO/ECOG performance status of 0 or 1.

Tumor assessments will be performed at Screening as baseline with follow-up every 6 weeks 1 week for the first 36 weeks, and then every 8 weeks 1 week until confirmed objective disease progression.

Details
Condition Small Cell Lung Cancer, sclc, small cell carcinoma, small cell carcinoma of the lung
Treatment cisplatin, etoposide, carboplatin, durvalumab, AZD2811
Clinical Study IdentifierNCT04745689
SponsorAstraZeneca
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented evidence of extensive stage SCLC (ES-SCLC)
Participants must be considered suitable to receive an induction platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC
No prior exposure to immune-mediated therapy
Life expectancy 12 weeks at Day 1
ECOG 0 or 1 at enrolment

Exclusion Criteria

Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy
Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
Active infection including tuberculosis, HIV, hepatitis B and C
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness, including but not limited to interstitial lung disease
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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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