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Chemotherapy

Chemo-Immunotherapy + Radiotherapy for Stage IV Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Ashish Saxena, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Adults ≥ 18 years old

Pathological diagnosis of SCLC from biopsy (core biopsy or fine needle aspiration); mixed-histology (NSCLC and SCLC) allowed

Must not have

Contraindications to platinum-based chemotherapy

Contraindications to radiation therapy

Timeline

Screening 2 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is for people with Stage IV small cell lung cancer who haven't started treatment yet. They'll get radiation therapy for 5 days, then standard chemo-immunotherapy for 4 cycles. They may keep getting durvalumab until their disease progresses.

Who is the study for?

This trial is for adults over 18 with untreated Stage IV small cell lung cancer. Participants must weigh more than 30kg, have a good performance status (able to carry out daily activities), and not have had prior immunotherapy or treatment for their lung cancer. They should be able to measure at least one lesion, have no major organ dysfunction, and women must not be pregnant and use birth control.

What is being tested?

The study tests radiation therapy followed by chemo-immunotherapy combining etoposide with either carboplatin or cisplatin plus durvalumab for four cycles. Patients may continue durvalumab post-cycles until disease progression. The goal is to assess the effectiveness of this combined treatment approach.

What are the potential side effects?

Possible side effects include reactions related to infusion treatments, fatigue, blood disorders like low platelet count or anemia, potential liver enzyme elevations indicating liver stress, kidney function changes due to creatinine clearance alterations, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer diagnosis came from a biopsy and is small cell lung cancer, possibly mixed with non-small cell lung cancer.

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My small cell lung cancer is at an advanced stage, not suitable for radiation due to its size or spread.

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My body weight is over 30kg.

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I have a tumor that can be measured and tracked over time.

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I have never received immunotherapy treatments.

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My white blood cell count is high enough without medication.

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My liver enzymes are within the required range for my cancer condition.

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My kidney function is good enough for certain chemotherapy drugs.

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I have received treatment for Small Cell Lung Cancer before.

Exclusion Criteria

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

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I cannot receive platinum-based chemotherapy due to health reasons.

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I cannot undergo radiation therapy due to health reasons.

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I have had radiation therapy at the same site where SBRT is proposed.

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I cannot stay still for radiation treatment.

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I have had cancer before, but it was a different type than my current diagnosis.

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My cancer was treated over 3 years ago, and it's unlikely to come back.

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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I had early-stage cancer that was treated, and now there's no sign of it.

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I was treated for early-stage small cell lung cancer with chemo and radiation at the same time.

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I am receiving treatment for an autoimmune condition linked to my cancer.

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My thyroid condition is stable with medication.

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I have a skin condition that doesn't need treatment with pills or injections.

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I do not have any serious ongoing illnesses that my doctor is not able to control.

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I am using steroids that are inhaled, nasal, topical, or injected into joints.

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I am allergic to durvalumab, etoposide, carboplatin, cisplatin, or their ingredients.

Timeline

Screening ~ 2 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months1 visit

Screening ~ 2 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 2 weeks for screening, Varies for treatment, and 12 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

Efficacy of multi-site, non-ablative radiation to standard systemic therapy for patients with extensive-stage small cell lung, as measured by a change in disease response

Number of toxicities Grade 3 or above related to therapy

Secondary study objectives

Objective response rate, determined by disease response rate defined by the RECIST 1.1 criteria

Overall survival, defined as the time from first study treatment to the time of death from any cause

Pattern of disease progression, defined by the progression in radiated lesions vs. non-radiated lesions and the rates of new lesions as determined by RECIST 1.1

Other study objectives

Evaluation of inflammatory protein composition in those that respond to treatment vs those that do not respond

Evaluation of the circulating immune cell in those that respond to treatment vs those that do not respond

Evaluation of the tumor-immune microenvironment in those that respond to treatment vs those that do not respond