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Monoclonal Antibodies

Durvalumab + Chemoradiation for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Led By Nathan A Pennell

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patient must not have unintentional weight loss > 10% within 30 days prior to registration

Newly diagnosed stage IIIA/B/C non-small cell lung cancer (NSCLC) (per the American Joint Committee on Cancer [AJCC] 8th edition) that is unresectable and is histologically and/or cytologically confirmed

Must not have

Patients with suspected cases of >= grade 2 pneumonitis (non-infectious) are not eligible for Step 2 consolidative MEDI4736 (durvalumab) and will proceed onto follow-up instead

Patient must not have had a prior allogeneic bone marrow transplantation or prior solid organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.

Who is the study for?

Adults with stage IIIA/B/C non-small cell lung cancer that can't be surgically removed, or those with nodal recurrence after early-stage surgery. Participants must not have lost more than 10% of their weight unintentionally in the last month, should use effective contraception, and have no severe allergies to antibodies or history of certain infections.

What is being tested?

The trial is testing if adding durvalumab (an antibody) to standard chemoradiation therapy and continuing it for a year improves outcomes compared to just chemoradiation followed by durvalumab. It's a phase III study aiming to see if this combination extends life or prevents cancer return.

What are the potential side effects?

Durvalumab may cause immune-related reactions affecting organs, infusion-related symptoms, fatigue, possible harm to unborn babies (hence contraception requirement), and increased risk of infection due to its action on the immune system.

Eligibility Criteria

Inclusion Criteria

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

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I have not lost more than 10% of my weight unintentionally in the last month.

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I have been diagnosed with stage IIIA/B/C non-small cell lung cancer that cannot be surgically removed.

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My cancer returned in the lymph nodes after early-stage lung cancer surgery.

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I have stage IIIA/B/C non-small cell lung cancer or it has come back in the nodes after surgery.

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I have not lost more than 10% of my weight unintentionally in the last month.

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I weigh more than 30 kilograms.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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I have stage IIIA/B/C non-small cell lung cancer that cannot be removed by surgery.

Exclusion Criteria

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

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I do not have severe lung inflammation.

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I have not had a bone marrow or organ transplant.

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I do not have an active tuberculosis infection.

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I have not had any treatment with specific antibodies or drugs.

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I have a history of disorders related to lymphocyte proliferation.

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I do not have any autoimmune or neuromuscular syndromes.

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I do not have an active hepatitis B or C infection.

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I have not had severe infections or sepsis in the last 2 weeks.

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I don't have lung conditions or active lung inflammation.

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I have not had a severe infection in the last 4 weeks.

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I have not had radiation on the area to be treated now.

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I will not donate blood or sperm while receiving the study treatment.

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I have a history of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 10 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

Overall survival (OS)

Secondary study objectives

Best objective response

Incidence of adverse events

Local progression

+1 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (durvalumab, chemotherapy, durvalumab)Experimental Treatment6 Interventions

STEP 1 (CONCURRENT THERAPY): Patients receive durvalumab IV over 60 minutes on days 1 and 15 of cycle 1 and day 1 of cycle 2. Patients also receive 1 of 3 treatment regimens per investigator choice: 1) etoposide IV over 60 minutes on days 1-5 and cisplatin IV over 60 minutes on days 1 and 8 every 28 days for 2 cycles; 2) pemetrexed disodium IV over 60 minutes and cisplatin IV over 60-120 minutes on day 1 every 21 days for 2 cycles; or 3) paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1 every 7 days for 6 cycles. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of chemotherapy, patients receive radiation therapy 5 days a week for 6 weeks. STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (chemotherapy, durvalumab)Active Control6 Interventions

STEP 1 (CONCURRENT THERAPY): Patients receive 1 of 3 investigator's choice treatment regimens and radiation therapy as in Arm A. STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Pemetrexed Disodium

2015

Completed Phase 2

~450