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Neoadjuvant Immunoradiation for Lung Cancer

Phase 2

Waitlist Available

Led By Patrick Forde, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Subjects with non-small cell lung cancer deemed surgically resectable by an attending thoracic surgeon with lobectomy

ECOG Performance Status 0-1

Must not have

History of allogenic organ transplantation

Active or prior documented autoimmune or inflammatory disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that combines immunotherapy and radiation. If it is safe, they will test it on more patients.

Who is the study for?

This trial is for adults over 18 with stage IIIA non-small cell lung cancer (NSCLC) that can be removed by surgery. Participants must weigh more than 30kg, have a life expectancy over 6 months, and be in good physical condition (ECOG Performance Status of 0-1). They should not have had certain prior treatments or conditions like chest radiation or active pneumonitis, and women must not be pregnant.

What is being tested?

The study tests 'immunoradiation' using durvalumab alone or combined with tremelimumab alongside standard thoracic radiation before surgical removal of the tumor. If safe, a second group will test both drugs with radiation pre-surgery. Post-surgery, standard chemotherapy may follow as decided by the doctor.

What are the potential side effects?

Possible side effects include immune-related inflammation in various organs, infusion reactions similar to allergic responses during drug administration, fatigue, digestive issues such as nausea and diarrhea, blood disorders like anemia or clotting problems, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer can be removed with surgery according to my thoracic surgeon.

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I am fully active or can carry out light work.

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My blood tests for bone marrow and organ function are normal.

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My condition is stage III non-small cell lung cancer.

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I am 18 years old or older.

Exclusion Criteria

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

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I have received an organ transplant from another person.

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I have or had an autoimmune or inflammatory disorder.

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I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.

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I have had lung inflammation treated with steroids or have ongoing lung inflammation.

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I don't have severe side effects from past cancer treatments.

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I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.

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I do not have any serious ongoing illnesses that could interfere with the study.

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I do not have active infections like TB, hepatitis B, C, or HIV.

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I have had radiation therapy to my chest before.

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A thoracic surgeon has determined I need a pneumonectomy.

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I have previously been treated with specific immune therapies or cancer vaccines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of Preoperative Immunoradiation

Toxicities as Measured by Number of Participants Experiencing Adverse Events

Secondary study objectives

Duration of Response as Measured by Recurrence-free Survival

Overall Survival

Percentage of Participants With Pathologic Response

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Durvalumab with RadiationExperimental Treatment4 Interventions

Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery

Group II: Durvalumab and Trememlimumab with RadiationExperimental Treatment5 Interventions

Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

FDA approved

Tremelimumab

Not yet FDA approved

0 / 16Eligibility criteria met