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

Conditions

• Stage III Lung Cancer AJCC v8
• Stage III Lung Non-Small Cell Cancer AJCC v7
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIA Lung Non-Small Cell Cancer AJCC v7
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIB Lung Non-Small Cell Cancer AJCC v7
• Stage IIIC Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Durvalumab — BIOLOGICAL
  Given IV
• Gemcitabine — DRUG
  Given IV
• Local Consolidation Therapy — PROCEDURE
  Undergo LCT
• Nab-paclitaxel — DRUG
  Given IV
• Paclitaxel — DRUG
  Given IV
• Pemetrexed — DRUG
  Given IV
• Quality-of-Life Assessment — OTHER
  Complete questionnaire
• Questionnaire Administration — OTHER
  Complete questionnaire

Study Details

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.

Key Dates

Start date

Jul 7, 2021

Status verified

Feb 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

51 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A (oligoprogressive)
  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.
• Experimental: Cohort B (polyprogressive)
  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.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From local consolidative therapy (LCT) initiation until progression or death, assessed up to 2 years ]

Locations (1)

Find similar trials in Houston, TX

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