RecruitingPhase 2NCT04892953

Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy

Local Consolidative Therapy (LCT) and Durvalumab (MEDI4736) for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy (ENDURE)


Sponsor

M.D. Anderson Cancer Center

Enrollment

51 participants

Start Date

Jul 7, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial finds out the effect of local consolidative therapy and durvalumab in treating patients with stage III non-small cell lung cancer that has 3 or fewer lesions of progression (oligoprogressive) and greater than 3 lesions of progression (polyprogressive) after chemoradiation and anti-PD-l1 therapy. Local consolidative therapy, such as surgery and/or radiation, after initial treatment may kill any remaining tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving local consolidative therapy and durvalumab may help to control the disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding more targeted radiation therapy (to the sites of cancer progression) plus continued immunotherapy with durvalumab can help patients with stage III non-small cell lung cancer (NSCLC) whose disease has progressed or persisted after completing standard chemoradiation plus durvalumab treatment. **You may be eligible if...** - You are 18 or older with stage III NSCLC - You received standard chemoradiation followed by durvalumab and your disease either progressed or persisted (shown on PET scan 6+ months after treatment, confirmed by biopsy) - Your disease has 3 or fewer new sites of progression (Cohort A) or more than 3 sites (Cohort B) - You have good performance status (ECOG 0–1) and adequate organ function - You are able to receive radiation therapy to at least one site **You may NOT be eligible if...** - Your disease rapidly progressed within the first 3 months of starting durvalumab after chemoradiation - You received a different immunotherapy drug than durvalumab - Your lung adenocarcinoma has mutations (EGFR, ALK, ROS1, RET, MET) with standard targeted therapy options - You have unresolved significant side effects from prior cancer treatment - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

Given IV

BIOLOGICALDurvalumab

Given IV

DRUGGemcitabine

Given IV

PROCEDURELocal Consolidation Therapy

Undergo LCT

DRUGNab-paclitaxel

Given IV

DRUGPaclitaxel

Given IV

DRUGPemetrexed

Given IV

OTHERQuality-of-Life Assessment

Complete questionnaire

OTHERQuestionnaire Administration

Complete questionnaire


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04892953


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