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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 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

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00350142
15%
ulcer
10%
vomiting
5%
Perforation
5%
pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT With Gem

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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: Radiation + Chemo-ImmunotherapyExperimental Treatment5 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Stereotactic Body Radiotherapy
2017
Completed Phase 2
~220
Carboplatin
FDA approved
Cisplatin
FDA approved
Etoposide
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,081 Previous Clinical Trials
1,137,997 Total Patients Enrolled
Ashish Saxena, MDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04951115 — Phase 2
Small Cell Lung Cancer Research Study Groups: Radiation + Chemo-Immunotherapy
Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04951115 — Phase 2
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04951115 — Phase 2
~10 spots leftby Oct 2025