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Chemotherapy

Chemo-Immunotherapy + Durvalumab + Ceralasertib for Small Cell Lung Cancer

Phase 2

Recruiting

Led By Muhammad Furqan, MD

Research Sponsored by Muhammad Furqan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to swallow and retain oral medication

Patient must be considered suitable to receive a platinum-based chemotherapy as 1st line treatment for ES-SCLC. Chemotherapy must contain either Carboplatin or Cisplatin in combination with Etoposide.

Must not have

Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of ceralasertib.

History of allogeneic stem cell or solid organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for small cell lung cancer that has not yet been approved. The goal is to see if it can help patients live longer without their cancer progressing.

Who is the study for?

Adults (18+) with untreated extensive stage small cell lung cancer suitable for platinum-based chemo (Carboplatin or Cisplatin with Etoposide). Must have measurable disease, proper organ function, and an ECOG Performance Status of 0-1. Women must use contraception and have a negative pregnancy test; men also need to agree to contraception. Excludes those with autoimmune diseases, prior SCLC therapy, certain infections like Hepatitis B/C or HIV, on strong CYP3A4 affecting drugs, severe nausea/vomiting issues, recent major surgery or live vaccines.

What is being tested?

This study tests the effectiveness of initial chemo-immunotherapy followed by maintenance therapy using Durvalumab and oral Ceralasertib in patients who haven't been treated before for extensive stage small cell lung cancer. The goal is to see how long patients can live without their cancer getting worse.

What are the potential side effects?

Possible side effects include immune-related reactions that may affect organs, infusion-related symptoms such as fever or chills during drug administration, fatigue, digestive problems like nausea or diarrhea, blood disorders which could lead to increased risk of infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow and keep down pills.

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I am deemed fit for a specific chemotherapy for small cell lung cancer.

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My cancer has spread extensively.

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I am 18 years old or older.

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I agree to use effective birth control during and 90 days after the study.

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My lung cancer is confirmed to be small cell type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe stomach issues that could affect how I absorb medication.

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I have had a transplant of stem cells or an organ from another person.

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I have a history of Ataxia telangiectasia.

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I do not have any serious ongoing health issues that my doctor hasn't been able to get under control.

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I have a history of Hepatitis B, C, or HIV but meet specific conditions for treatment eligibility.

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I have had treatment for extensive or recurrent small cell lung cancer.

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I am not taking strong drugs that affect liver enzyme CYP3A4.

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I have an active case of tuberculosis.

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I weigh 30 Kg or less.

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My small cell lung cancer has returned after treatment.

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I am currently being treated for a serious infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Disease Control Rate

Duration of Response

Objective response rate (ORR)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cisplatin or Carboplatin + Etoposide + Durvalumab + CeralasertibExperimental Treatment5 Interventions

Initial Phase: Cycles 1-4 Cisplatin or Carboplatin: Day 1 Etoposide: Days 1-3 Durvalumab, 1500 mg: Day 1 q 3 weeks Maintenance Phase, Cycles 5+ Durvalumab, 1500 mg: Day 8 q 4 wks. Ceralasertib at 240mg po BID twice a day: Days 1-7

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ceralasertib

2017

Completed Phase 1

~40

Carboplatin

2014

Completed Phase 3

~6120