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PD-L1 Inhibitor

Local Consolidative Therapy + Durvalumab for Lung Cancer

Phase 2

Recruiting

Led By Percy P Lee

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Stage III NSCLC (AJCC 7th and 8th edition) patients who received standard chemoradiation followed by durvalumab therapy with either progressive disease or persistent disease. Persistent disease defined as residual positron emission tomography (PET) avidity 6 months after completion of initial definitive therapy and confirmed with biopsy

Measured creatinine clearance (CL) > 15 mL/min or calculated creatinine CL > 15 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance

Must not have

History of another primary malignancy except for

History of leptomeningeal carcinomatosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This triallooks at treating lung cancer with surgery/radiation & immunotherapy to control disease.

Who is the study for?

This trial is for adults with stage III non-small cell lung cancer who've had chemoradiation and anti-PD-L1 therapy but still have up to 3 progressing lesions (oligoprogressive) or more than 3 (polyprogressive). They should be fit for radiation, have a life expectancy of at least 12 weeks, and their major organs must function within certain limits. People with certain genetic mutations or unresolved severe side effects from previous treatments can't join.

What is being tested?

The trial tests if adding local consolidative therapy (like surgery/radiation) to durvalumab immunotherapy helps control the disease better in patients whose cancer has progressed after initial treatments. It aims to see if this combination can kill remaining tumor cells and boost the immune system's ability to fight cancer.

What are the potential side effects?

Durvalumab may cause immune-related reactions affecting various organs, fatigue, infusion reactions similar to allergic responses, digestive issues like diarrhea or colitis, skin problems such as rash or itching, hormonal imbalances, 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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I have stage III lung cancer, treated with chemoradiation and durvalumab, but my cancer either worsened or didn't fully respond.

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My kidney function, measured by creatinine clearance, is above 15 mL/min.

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I am a candidate for radiation therapy on at least one cancer lesion.

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My cancer has spread to more than 3 areas, but multiple chest lesions count as one.

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I am fully active or can carry out light work.

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My body weight is over 30 kg.

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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 had cancer before, but it was a different type.

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I have had cancer spread to the lining of my brain and spinal cord.

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I do not have any serious ongoing illnesses that would affect my participation in the study.

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I am not in another treatment study while starting this one, except for observational studies.

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I have previously received treatments targeting PD-1, PD-L1, or CTLA-4.

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I have been treated with an anti-PD-(L)1 therapy, but not durvalumab.

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My cancer worsened quickly after starting treatment with durvalumab following chemoradiotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Progression free survival (PFS)

Secondary study objectives

OS2

Overall survival (OS)1

Quality of life questionnaires

+3 more

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 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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: Cohort B (polyprogressive)Experimental Treatment9 Interventions

Patients undergo LCT consisting of radiation therapy and/or surgery, then receive durvalumab IV over 1 hour on day 1. Patients also receive one of the following chemotherapy options: carboplatin and paclitaxel on day 1, carboplatin on day 1 and nab-paclitaxel on days 1, 8, 15, or carboplatin on day 1 and gemcitabine on days 1 and 8. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with non-squamous histology receive pemetrexed on day 1 every 21 days for cycles 1-4, pemetrexed and durvalumab IV on day 1 every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Cohort A (oligoprogressive)Experimental Treatment4 Interventions

Patients undergo LCT consisting of radiation therapy and/or surgery, then receive durvalumab IV over 1 hour on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

FDA approved

Paclitaxel

FDA approved

Gemcitabine

FDA approved

Durvalumab

FDA approved