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Chemo-Immunotherapy Followed by Durvalumab and Ceralasertib in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer

ConditionExtensive Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMuhammad Furqan

About this trial

The primary objective of this single arm study is to estimate the progression free survival of previously-untreated patients with extensive stage small cell lung cancer. Patients will receive initial chemo-immunotherapy followed by maintenance therapy with durvalumab and oral ceralasertib.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

Age >= 18 years at the time of consent.

ECOG Performance Status of 0-1 within 14 days prior to registration (Appendix A of Protocol).

Histological or cytological confirmed small cell lung carcinoma

Disqualifiers

Prior systemic therapy for extensive stage or recurrent SCLC

Patients with recurrent SCLC, who received chemotherapy or definitive chest radiation in the past for limited-stage SCLC.

Clinically significant active infection requiring systemic therapy

Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).

Trial design

Design model

Single group

Treatments tested in this trial

  • Cisplatin

    Drug

    Cisplatin

  • Carboplatin

    Drug

    Carboplatin

  • Etoposide

    Drug

    Etoposide

  • Durvalumab

    Drug

    Durvalumab

  • Ceralasertib

    Drug

    Ceralasertib

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Cisplatin or Carboplatin + Etoposide + Durvalumab + CeralasertibExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Progression free survival (PFS) is defined as the time from the initiation of treatment (C1D1) to the time when the criteria for disease progression is met as defined by RECIST v1.1 OR death due to any cause. The PFS is subject to right censoring due to loss to follow-up or at the end of study duration.

Time frame
From enrollment until the time of disease progression, assessed for a maximum of 24 months

Secondary outcomes

1

Time to disease progression

Time to disease progression: Will be measured from C1D1 of treatment until the criteria for disease progression is met as defined by RECIST 1.1

Time frame
From enrollment until the time of disease progression,assessed for a maximum of 24 months
2

Time to CNS Progression

Time to CNS progression: Will be measured from C1D1 of treatment until the criteria for disease progression is met in the CNS (intracranial) by RECIST 1.1 criteria. Patients with CNS -only progression or those with concurrent CNS and systemic progression will be included in this analysis.

Time frame
From enrollment until the time of cns progression, assessed for a maximum of 24 months
3

Time to Systemic Progression

Time to Systemic progression: Will be measured from C1D1 of treatment until the criteria for systemic disease (extracranial) progression is met by RECIST 1.1. Patients with systemic-only or those with concurrent CNS and systemic progression will be included in this analysis.

Time frame
From enrollment until the time of systemic progression, assessed for a maximum of 24 months
4

Progression free survival for maintenance therapy

Progression free survival for maintenance therapy: Will be measured from C5D1 of first maintenance therapy until the criteria for disease progression is met as defined by RECIST 1.1

Time frame
From Cycle 5, Day 1 of maintenance therapy until disease progression, assessed for a maximum of 19 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Muhammad Furqan

Lead sponsor

Big Ten Cancer Research Consortium

Sponsor institution

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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